An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa With Correlative Analysis.

This is a phase 2a, open label study.
As psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.

开始日期2025-09-01

申办/合作机构

Arcutis Biotherapeutics, Inc.

NCT07105254

/ Not yet recruitingN/AIIT

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)

An open-label single center, proof of concept study evaluating the efficacy of Roflumilast foam 0.3% in pediatric subjects with Non-Segmental Vitiligo (NSV)

开始日期2025-08-01

申办/合作机构-

NCT06977711

/ Recruiting临床1期IIT

Phase Ib Clinical Trial of Loncastuximab and Roflumilast Added to R-CHOP (Lo-RR-CHOP) for Treatment Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants.
The aims are:
1. To assess the safety and how well the participants tolerate the treatment
2. Assess the response of the tumor to treatment to estimate complete response
3. Assess the response of the tumor to treatment to estimate progression-free survival

开始日期2025-06-20

申办/合作机构

University of Texas Health Science Center At San Antonio

100 项与罗氟司特相关的临床结果

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100 项与罗氟司特相关的转化医学

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100 项与罗氟司特相关的专利（医药）

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1,137

项与罗氟司特相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study

Article

作者: Yilmaz, Orhan ; Torres, Tiago ; Lé, Ana Maria ; Luz, Martim

OBJECTIVE:

Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.

METHODS:

Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.

RESULTS:

Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.

CONCLUSION:

Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.

2025-12-01·INFLAMMATION RESEARCH

Selective phosphodiesterase 4 inhibitor roflumilast reduces inflammation and lung injury in models of betacoronavirus infection in mice

Article

作者: Lacerda, Larisse de Souza Barbosa ; da Silva, Walison Nunes ; Martins, Débora Gonzaga ; Martins, Flávia Rayssa Braga ; Soriani, Frederico Marianetti ; Guimaraes, Pedro Pires Goulart ; Pinho, Vanessa ; Félix, Franciel Batista ; Costa, Vivian Vasconcelos ; Costa, Victor Rodrigues de Melo ; Teixeira, Mauro Martins ; Beltrami, Vinícius Amorim ; Queiroz-Junior, Celso Martins ; Santos, Felipe Rocha da Silva ; Guimaraes, Goulart ; Resende, Letícia Cassiano

OBJECTIVE:

We aimed to understand the potential therapeutic and anti-inflammatory effects of the phosphodiesterase-4 (PDE4) inhibitor roflumilast in models of pulmonary infection caused by betacoronaviruses.

METHODS:

Mice were infected intranasally with murine hepatitis virus (MHV-3) or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Roflumilast was given to MHV-3-infected mice therapeutically at doses of 1 mg/kg or 10 mg/kg, or prophylactically at 10 mg/kg. In SARS-CoV-2-infected mice, roflumilast was given therapeutically at a dose of 10 mg/kg. Lung histopathology, chemokines (CXCL-1 and CCL2), cytokines (IL-1β, IL-6, TNF, IFN-γ, IL-10 and TGFβ), neutrophil immunohistochemical staining (Ly6G⁺ cells), macrophage immunofluorescence staining (F4/80⁺ cells), viral titration plaque assay, real-time PCR virus detection, and blood cell counts were examined.

RESULTS:

Therapeutic treatment with roflumilast at 10 mg/kg reduced lung injury in SARS-CoV-2 or MHV-3-infected mice without compromising viral clearance. In MHV-3-infected mice, reduced lung injury was associated with decreased chemokines levels, prevention of neutrophil aggregates and reduced macrophage accumulation in the lung tissue. However, the prophylactic treatment strategy with roflumilast increased lung injury in MHV-3-infected mice.

CONCLUSION:

Our findings indicate that therapeutic treatment with roflumilast reduced lung injury in MHV-3 and SARS-CoV-2 lung infections. Given the protection induced by roflumilast in inflammation, PDE4 targeting could be a promising therapeutic avenue worth exploring following severe viral infections of the lung.

2025-10-01·CELLULAR SIGNALLING

Roflumilast inhibits neuronal ferroptosis via AMPK/Nrf2/HO-1 signaling and promotes motor function recovery after spinal cord injury in rats

Article

作者: Han, YaoNan ; Yu, DeShui ; Wang, XingTong

Spinal cord injury (SCI) is a serious central nervous system disease. Ferroptosis is one of the major causes of spinal cord neurological loss, and targeting ferroptosis is a promising therapeutic strategy. Roflumilast has shown promising applications in the treatment of neurological diseases due to its potent anti-inflammatory and anti-oxidative stress effects. This study aimed to investigate whether roflumilast could inhibit neuronal ferroptosis to improve motor function after SCI in rats. In vitro experiments, we found that roflumilast significantly increased cell survival in an in vitro ferroptosis model, improved mitochondrial function, reduced intracellular iron, reactive oxygen species (ROS), and lipid peroxides accumulation as well as the expression of the pro-ferroptosis proteins, long-chain acyl-coenzyme A synthase 4 (ACSL4), and prostaglandin-endoperoxide synthase 2 (PTGS2), and increased the expression of ferroptosis-inhibitory protein glutathione peroxidase 4 (GPX4), and ferritin heavy chain 1 (FTH1) expression. Mechanistically, these protective effects were achieved by activating AMP-dependent protein kinase (AMPK)/nuclear factor E2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling and were attenuated when AMPK signaling was blocked. In vivo experiments, roflumilast attenuated spinal cord tissue damage, increased the number of motor neuron survivors, and improved motor function after SCI in rats. Overall, activation of AMPK/Nrf2/HO-1 signaling by roflumilast attenuated neuronal ferroptosis and improved motor function after SCI in rats.

295

项与罗氟司特相关的新闻（医药）

2025-09-03

·investors.arcutis.com

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children Ages 2 to 5

If approved, ZORYVE cream would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, offering patients and caregivers an important alternative to topical steroids and vitamin-D analogs ZORYVE cream is uniquely formulated to be effective, safe, and well tolerated for all areas of the body, including sensitive areas such as intertriginous skin, where plaque psoriasis often presents in children WESTLAKE VILLAGE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication of ZORYVE® (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2. If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor treatment indicated for plaque psoriasis in children down to age 2. “Today, there are very limited FDA-approved treatment options for plaque psoriasis for children under 6, who often present with disease on sensitive skin such as the face and intertriginous areas. There is a significant unmet need for non-steroidal options that can effectively treat plaque psoriasis over the long-term,” said Adelaide Hebert, MD, professor and chief of pediatric dermatology at UTHealth Houston. “If approved, investigational ZORYVE cream could be an important first-line treatment option for children as young as age 2.” Plaque psoriasis is the most common form of psoriasis in young children and presents with similar clinical features to those seen in adults. However, in children — particularly those under 6 — psoriasis often appears in sensitive areas, such as the face or intertriginous areas, increasing the challenge of safe long-term management. ZORYVE cream is a once-daily, steroid-free, non-greasy cream that does not include sensitizing excipients or irritants such as propylene glycol, polyethylene glycol, ethanol, or fragrances. It is the only topical treatment specifically indicated for intertriginous psoriasis and has demonstrated efficacy, safety, and tolerability across adults and children. “This submission represents another important step forward in our goal to establish ZORYVE as foundational therapy for young children suffering with inflammatory skin diseases,” said Frank Watanabe, president and CEO at Arcutis. “Historically, many treatments for inflammatory skin diseases were not studied in children, creating challenges for the clinicians who treat these vulnerable patients. Arcutis is committed to helping to address this gap in treatment through conducting trials of ZORYVE in pediatric patients across a range of inflammatory skin diseases.” ZORYVE cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2 to 5 years with plaque psoriasis, as well as data from a long-term open-label study. Results from the long-term study demonstrate consistent favorable long-term safety and tolerability as well as persistence of efficacy across the age ranges studied. About Plaque Psoriasis Psoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, flaking, and pain. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin area. In children, psoriasis more commonly affects these sensitive areas and intertriginous regions, posing treatment challenges and quality-of-life burdens for patients and families. About ZORYVE® (roflumilast)ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined — atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a next-generation, highly potent and selective topical PDE4 inhibitor. PDE4, an established target in dermatology, is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. ZORYVE (roflumilast) cream 0.3% is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Recently, both ZORYVE cream 0.3% and ZORYVE foam 0.3% were awarded the National Psoriasis Foundation’s Seal of Recognition — the first FDA-approved product to receive the honor. INDICATIONS ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATIONZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval for ZORYVE cream 0.3% as a treatment for plaque psoriasis in children ages 2 to 5 years. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. ContactsMediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

上市批准

2025-08-06

·investors.arcutis.com

Arcutis Announces Second Quarter 2025 Financial Results and Provides Business Update

Q2 2025 net product revenue for ZORYVE® (roflumilast) was $81.5 million, a 164% increase compared to Q2 of 2024, and a 28% increase compared to Q1 of 2025, driven by strong portfolio demand growth ZORYVE foam 0.3% received U.S. Food and Drug Administration (FDA) approval for the treatment of plaque psoriasis of the scalp and body in adults and adolescents 12 years of age and older Initiated INTEGUMENT-INFANT study to evaluate the safety and efficacy of ZORYVE cream 0.05% in infants with atopic dermatitis ages 3 months to 24 months Submitted Investigational New Drug Application (IND) for ARQ-234, a novel fusion protein for the potential treatment of patients with atopic dermatitis WESTLAKE VILLAGE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update. “We continue to advance our strategy to become the leading medical dermatology company. This quarter, we generated strong net product revenues of $81.5 million from our ZORYVE portfolio, launched a new indication for ZORYVE foam for scalp and body psoriasis, and continued to advance our pipeline. Demand for ZORYVE continues to grow steadily, and we recently surpassed 1 million prescriptions dispensed, underscoring clinicians’ trust in ZORYVE as their preferred steroid-free topical treatment across our four approved indications, thanks to its consistent, robust efficacy and favorable safety and tolerability,” said Frank Watanabe, president and chief executive officer. “Looking ahead, we remain focused on expanding the approved uses of ZORYVE to the youngest patients, with the potential Q4 approval of ZORYVE cream 0.05% for 2 to 5 year olds with atopic dermatitis and the initiation of an infant atopic dermatitis study. Together with our efforts to evaluate potential further indications for ZORYVE and the continued advancement of ARQ-234, we are well positioned for long-term, sustainable growth.” Program Updates / Key Milestones ZORYVE cream - a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in a once-daily cream formulation, approved in the United States for the treatment of plaque psoriasis and atopic dermatitis. U.S. demand for ZORYVE cream 0.3% in plaque psoriasis continues to grow, with over 439,000 prescriptions filled since launch, reflecting the high levels of patient and physician satisfaction with the ZORYVE cream clinical profile. Launch of ZORYVE cream 0.15% in atopic dermatitis continues to gain momentum with over 99,000 prescriptions filled since launch. ZORYVE cream 0.15% received a strong recommendation from the American Association of Dermatology (AAD) in its recently updated guidelines for atopic dermatitis treatments for adults. The Company has been assigned a Prescription Drug User Fee Act (PDUFA) action date of October 13, 2025 for the supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5 years old. In addition, the Company commenced a four-week Phase 2 study to evaluate investigational, once-daily ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis, which could potentially be the basis for further indication expansion. ZORYVE foam - a once-daily foam formulation of topical roflumilast designed to overcome the challenges of delivering topical drugs in hair-bearing areas of the body, approved in the United States for the treatment of seborrheic dermatitis and plaque psoriasis of the scalp and body. The Company received FDA approval for its sNDA for ZORYVE foam for scalp and body psoriasis in adult and adolescents 12 years of age and older in May 2025 and commenced sales in June 2025. Demand for ZORYVE foam 0.3% in seborrheic dermatitis and plaque psoriasis of the scalp and body continues to grow robustly each quarter, with over 405,000 prescriptions filled since launch, reflecting the high unmet need in these diseases. ARQ-234 - a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis. The Company submitted its IND for ARQ-234 in July 2025. Other Pipeline Updates Following the evaluation of results from the Phase 1b trial of ARQ-255, a penetrating topical formulation of ivarmacitinib for the treatment of alopecia areata, the Company has elected to halt further development of this program. While clinical and biomarker results indicated some level of efficacy, the results did not meet the Company's threshold for advancement, and the Company has deprioritized the program given other R&D priorities across its portfolio. The Company has begun to investigate further indication expansion opportunities for ZORYVE, beginning with two recently initiated Phase 2 studies. Recent Corporate Highlights ZORYVE cream and ZORYVE foam received the Seal of Recognition from the National Psoriasis Foundation (NPF) in June 2025, the first time that the NPF has recognized a prescription product. ZORYVE cream 0.15% received a strong recommendation in the updated AAD guidelines for atopic dermatitis treatments for adults. The Company's successful pivotal Phase 3 ARRECTOR trial for ZORYVE foam 0.3% in scalp and body psoriasis was published in the Journal of the American Medical Association Dermatology in May 2025. Obtained three new U.S. patents in Q2 2025 related to topical roflumilast compositions. Second Quarter 2025 Summary Financial Results Product revenues for the quarter ended June 30, 2025 were $81.5 million compared to $30.9 million for the corresponding period in 2024. Revenues for the quarter were $27.7 million for ZORYVE cream 0.3%, $14.6 million for ZORYVE cream 0.15%, and $39.2 million for ZORYVE topical foam 0.3%. Year-over-year and quarter-over-quarter increases were due to increased unit demand. Gross-to-net (GTN) rates remain favorable for ZORYVE, driven by a high percentage of prescriptions being reimbursed. Cost of sales for the quarter ended June 30, 2025 were $7.5 million compared to $3.5 million for the corresponding period in 2024 due to increasing ZORYVE sales. Research and development (R&D) expenses for the quarter ended June 30, 2025 were $19.5 million compared to $19.3 million for the corresponding period in 2024. Expenses remained consistent year-over-year as decreased development costs for roflumilast in adult atopic dermatitis and plaque psoriasis were partially offset by an increase in development costs for pediatric atopic dermatitis and continued medical affairs investments to support medical education. Selling, general, and administrative (SG&A) expenses for the quarter ended June 30, 2025 were $69.2 million compared to $58.2 million for the corresponding period in 2024. The year-over-year increase was primarily driven by increased sales and marketing and personnel-related expenses due to our continued commercialization efforts for ZORYVE. Net loss was $15.9 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2025 compared to $52.3 million, or $0.42 per basic and diluted share, for the corresponding period in 2024. Cash, cash equivalents, restricted cash, and marketable securities were $191.1 million as of June 30, 2025, compared to $228.6 million as of December 31, 2024. Net cash provided by operating activities was $0.3 million during the second quarter as increased gross profit and timing changes in net working capital reduced cash used in operations. The company made the $10.0 million cash milestone payment to AstraZeneca for reaching a sales milestone of $250 million that was incurred in the first quarter of 2025, which is included as an investing activity. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed at the “Events” section of the Company’s website. The replay of the webcast will be available on the Arcutis website following the call. About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline for inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, approval, and potential commercialization of product candidates; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis, including market access and reimbursement, product demand growth and developments regarding GTN; and the timing of regulatory filings and potential approvals. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, Head of Investor Relationsir@arcutis.com

临床结果上市批准临床3期临床2期临床1期

2025-07-30

·华东医药股份有限公司

华东医药创新皮肤外用制剂0.15%罗氟司特乳膏中国Ⅲ期临床达到主要研究终点

近日，华东医药全资子公司杭州中美华东制药有限公司（简称“中美华东”）获得创新皮肤外用制剂0.15%罗氟司特乳膏中国轻中度特应性皮炎Ⅲ期临床试验的顶线数据。初步结果表明，0.15%罗氟司特乳膏在中国6岁及以上的轻中度特应性皮炎患者中表现出积极的疗效和良好的安全性，达成研究主要终点。本研究为一项多中心、随机、双盲、赋形剂对照的Ⅲ期临床研究，以评估每日一次0.15%罗氟司特乳膏在≥6岁中国轻中度特应性皮炎受试者中的有效性、安全性和PK特征。研究由复旦大学附属华山医院的徐金华教授牵头，在全国60家临床中心开展，实际入组354例受试者，其中试验组235例，赋形剂组119例。近日，该研究已完成了顶线分析。主要终点是第4周达到研究者总体评估（IGA）治疗成功的受试者比例，治疗组为31.9%，赋形剂组为6.7%(P<0.0001)。IGA成功定义为评分为“0”或“1”分且较基线改善≥2分。次要终点指标：治疗4周的湿疹面积及严重程度指数（EASI）-75（即EASI较基线期降低≥75%）达标率，治疗组为41.3%，赋形剂组为16.3%(P<0.0001)。此外，其他次要终点指标最严重瘙痒-数字评分 (WI-NRS)等，治疗4周后治疗组均显著优于赋形剂组。研究结果显示，0.15%罗氟司特乳膏在受试者中安全性、耐受性良好，整体安全性特征与技术开发方Arcutis Biotherapeutics公司海外研究数据类似，没有发生治疗相关的严重不良事件（SAE），未发现新增安全性信号。本次0.15%罗氟司特乳膏中国轻中度特应性皮炎适应症的Ⅲ期临床达到主要研究终点，是该系列产品研发进程中的重要里程碑，将进一步提升公司在自身免疫领域和皮肤外用制剂领域的核心竞争力。公司正积极准备递交该适应症的中国上市申请。关于0.15%罗氟司特乳膏0.15%罗氟司特乳膏（美国市场商品名称：ZORYVE®）是由Arcutis Biotherapeutics, Inc.开发，中美华东于2023年引进的创新皮肤外用制剂，中美华东拥有该产品在大中华区及东南亚的独家许可，包括开发、注册、生产及商业化权益。0.15%罗氟司特乳膏的活性成分Roflumilast（罗氟司特）是一种磷酸二酯酶-4（PDE4）抑制剂。PDE4作为一种细胞内酶，可增加促炎介质的生成并减少抗炎介质的生成，抑制PDE4可减轻炎症反应。ZORYVE®已于2024年7月获得美国FDA批准，用于治疗6岁及以上患者的轻度至中度特应性皮炎。声明1、本新闻旨在分享公司（或合作伙伴）研发工作的前沿进展资讯，非广告用途，相关信息并非针对患者，仅供医疗卫生专业人士参考使用；2、本新闻稿中内容不涉及对任何药品和/或适应症作推荐；3、本新闻稿中涉及的信息仅供参考，具体信息以公司在深圳证券交易所发布的文件为准。公司新闻稿和公告不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导；4、截至本文发布，0.15%罗氟司特乳膏尚未被国家药品监督管理局批准上市；5、本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床3期临床结果临床成功免疫疗法

100 项与罗氟司特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05744	罗氟司特	R03DX07	DB01656

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
特应性皮炎	美国	Arcutis Biotherapeutics, Inc.	2024-07-10
脂溢性皮炎	美国	Arcutis Biotherapeutics, Inc.	2023-12-15
斑块状银屑病	加拿大	Arcutis Biotherapeutics, Inc.	2019-12-20
慢性阻塞性肺疾病	欧盟	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	冰岛	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	列支敦士登	AstraZeneca AB	2010-07-05
慢性阻塞性肺疾病	挪威	AstraZeneca AB	2010-07-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
轻度特应性皮炎	临床3期	中国	Arcutis Biotherapeutics, Inc.	2024-11-21
轻度特应性皮炎	临床3期	中国	杭州中美华东制药有限公司	2024-11-21
中度特应性皮炎	临床3期	中国	杭州中美华东制药有限公司	2024-11-21
中度特应性皮炎	临床3期	中国	Arcutis Biotherapeutics, Inc.	2024-11-21
头皮银屑病	临床3期	美国	Arcutis Biotherapeutics, Inc.	2021-08-24
头皮银屑病	临床3期	加拿大	Arcutis Biotherapeutics, Inc.	2021-08-24
慢性大斑块银屑病	临床3期	美国	Arcutis Biotherapeutics, Inc.	2020-02-12
慢性大斑块银屑病	临床3期	加拿大	Arcutis Biotherapeutics, Inc.	2020-02-12
慢性大斑块银屑病	临床3期	多米尼加共和国	Arcutis Biotherapeutics, Inc.	2020-02-12
哮喘	临床3期	美国	AstraZeneca PLC	2003-11-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06631170 (NEWS) 人工标引	临床3期	中度特应性皮炎 \| 特应性皮炎	354	0.15%罗氟司特	餘範窪鹹齋積鏇膚鬱範(築願遞繭淵糧網構鑰簾) = 觸觸鹹鬱鹹範淵壓壓淵艱繭觸鑰艱鏇選窪遞顧 (觸艱積衊構壓醖憲鏇繭 ) 达到更多	积极	2025-07-30
				赋形剂	餘範窪鹹齋積鏇膚鬱範(築願遞繭淵糧網構鑰簾) = 鏇艱鑰遞鹹醖顧淵顧窪艱繭觸鑰艱鏇選窪遞顧 (觸艱積衊構壓醖憲鏇繭 ) 达到更多
NCT05028582 (ARRECTOR, CTgov)	临床3期	头皮银屑病	432	Roflumilast Foam 0.3% (Roflumilast Foam 0.3%)	繭鹹廠遞鏇鑰淵襯顧鬱 = 鏇顧製鹽衊膚蓋窪鑰廠鹽網鑰糧夢鹹淵顧醖顧 (鬱糧鑰齋淵衊膚遞壓選, 積鹹蓋製獵憲鬱鏇鹹選 ~ 蓋餘鏇襯壓築簾願願築) 更多	-	2025-07-17
				Vehicle Foam (Vehicle Foam)	繭鹹廠遞鏇鑰淵襯顧鬱 = 鏇窪構選願齋鹹願蓋糧鹽網鑰糧夢鹹淵顧醖顧 (鬱糧鑰齋淵衊膚遞壓選, 鹹獵願鏇願醖艱鏇鹽鹽 ~ 膚製獵壓遞網觸選製鬱) 更多
NCT05028582 (ARRECTOR, AAD2025) 人工标引	临床3期	银屑病	432	roflumilast foam 0.3%roflumilast foam 0.3%	築簾範鹹築憲願築願簾(獵襯糧構衊艱積觸糧艱) = 顧窪構觸獵觸觸艱餘簾齋夢艱願憲積網襯選鹹 (膚憲鑰遞餘選壓製選獵 ) 更多	积极	2025-03-07
				vehicle	築簾範鹹築憲願築願簾(獵襯糧構衊艱積觸糧艱) = 顧廠夢繭願觸選築壓齋齋夢艱願憲積網襯選鹹 (膚憲鑰遞餘選壓製選獵 ) 更多
NCT04773587 \| NCT04773600 (INTEGUMENT-2, AAD2025 \| Company_Website) 人工标引	临床3期	特应性皮炎	1,337	Roflumilast creamRoflumilast cream 0.15%	夢遞糧鬱製鬱襯遞願窪(襯範網蓋艱網鑰鹽製艱) = 醖壓觸觸願襯膚範積構鹽築窪鹽艱齋窪膚顧壓 (鑰醖鏇鏇壓膚鹹鬱膚鏇 ) 更多	积极	2025-03-07
				Vehicle cream	夢遞糧鬱製鬱襯遞願窪(襯範網蓋艱網鑰鹽製艱) = 衊遞壓築餘衊窪範廠糧鹽築窪鹽艱齋窪膚顧壓 (鑰醖鏇鏇壓膚鹹鬱膚鏇 ) 更多
NCT04845620 (INTEGUMENT-PED, Company_Website) 人工标引	临床3期	中度特应性皮炎 \| 特应性皮炎	652	0.05% ZORYVEZORYVE	觸遞築窪餘齋築窪鏇鹹(鬱餘獵鹹鹽鑰遞網簾夢) = 壓膚網鹹廠窪鬱壓選淵膚鏇膚齋齋簾網築襯遞 (襯餘製夢醖膚廠選繭願 ) 更多	积极	2025-02-24
				vehicle-controlled	觸遞築窪餘齋築窪鏇鹹(鬱餘獵鹹鹽鑰遞網簾夢) = 鏇觸醖醖壓醖鏇窪構構膚鏇膚齋齋簾網築襯遞 (襯餘製夢醖膚廠選繭願 ) 更多
NCT04773587 \| NCT04773600 (INTEGUMENT-2, ACAAI2024 \| GlobeNewswire) 人工标引	临床3期	特应性皮炎	-	Roflumilast cream 0.15%	襯鑰願廠餘醖遞鏇醖窪(觸餘蓋簾鬱艱積構鹽鹹) = 繭壓襯淵網鬱衊憲顧選衊齋醖襯獵選願築淵夢 (鏇願鏇窪築構鑰簾顧淵 ) 更多	积极	2024-10-24
				Vehicle	襯鑰願廠餘醖遞鏇醖窪(觸餘蓋簾鬱艱積構鹽鹹) = 鹽簾顧構鹽醖構糧壓廠衊齋醖襯獵選願築淵夢 (鏇願鏇窪築構鑰簾顧淵 ) 更多
NCT04773587 (INTEGUMENT-I \| INTEGUMENT-1 \| INTEGUMENT-1, CTgov)	临床3期	特应性皮炎	654	Roflumilast Cream 0.15% (Roflumilast Cream 0.15%)	製夢製衊餘廠遞積鬱願 = 鏇鹹醖廠繭鑰鹽壓觸艱膚選窪餘淵築鏇觸觸範 (繭夢鑰餘艱蓋積憲構選, 膚膚構構鏇廠選鹽獵鏇 ~ 繭夢蓋簾繭艱醖糧廠積) 更多	-	2024-10-09
				Vehicle Cream (Vehicle Cream)	製夢製衊餘廠遞積鬱願 = 膚網築鹽齋積壓餘壓獵膚選窪餘淵築鏇觸觸範 (繭夢鑰餘艱蓋積憲構選, 築窪築憲簾製鹹蓋構餘 ~ 顧遞壓製鬱選鹹襯觸壓) 更多
NCT04773600 (INTEGUMENT-II \| INTEGUMENT-2, CTgov)	临床3期	特应性皮炎	683	Roflumilast Cream (Roflumilast Cream 0.15%)	襯選廠網窪範壓艱淵襯 = 窪餘鏇積獵鏇鬱衊憲構淵範淵糧鏇醖願獵餘鏇 (糧襯餘夢鹹鑰遞膚窪艱, 築窪鑰觸鏇衊壓糧夢製 ~ 膚糧鏇壓積窪鏇鏇艱衊) 更多	-	2024-10-04
				Vehicle cream (Vehicle Cream)	襯選廠網窪範壓艱淵襯 = 積廠餘糧淵淵觸齋糧糧淵範淵糧鏇醖願獵餘鏇 (糧襯餘夢鹹鑰遞膚窪艱, 鑰獵夢艱夢齋簾鹹襯餘 ~ 製積繭窪淵繭製蓋夢網) 更多
NCT04773587 \| NCT04773600 (Literature) 人工标引	临床3期	特应性皮炎	1,337	Roflumilast cream, 0.15% (INTEGUMENT-1)	願鹽醖鹽獵膚窪選鹽膚(顧觸醖觸製鹽鹹艱鹽蓋) = 廠鹹鹽餘夢鬱鹽鏇糧廠選鹹觸憲糧鹽醖構獵構 (製簾艱積壓遞艱糧觸選 ) 更多	积极	2024-09-18
				Vehicle cream (INTEGUMENT-1)	願鹽醖鹽獵膚窪選鹽膚(顧觸醖觸製鹽鹹艱鹽蓋) = 淵鹽膚積夢構衊夢齋遞選鹹觸憲糧鹽醖構獵構 (製簾艱積壓遞艱糧觸選 ) 更多
NCT04445987 (phase 2, CTgov)	临床2期	脂溢性皮炎	408	ARQ-154-203 Roflumilast Foam (Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)	遞顧鑰醖願範製鹹構繭 = 簾膚蓋淵積築夢簾艱壓艱構餘顧蓋淵蓋壓淵蓋 (製窪鹽鬱遞鑰憲淵壓遞, 齋憲蓋繭築鹹餘艱鹽窪 ~ 顧鹽願餘積獵築鹽構積) 更多	-	2024-06-11
				ARQ-154-203 Roflumilast Foam (Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)	遞顧鑰醖願範製鹹構繭 = 鬱衊鹹齋範壓顧獵積襯艱構餘顧蓋淵蓋壓淵蓋 (製窪鹽鬱遞鑰憲淵壓遞, 衊憲壓築鹹淵醖遞憲廠 ~ 獵網範淵觸繭鏇築艱齋)