A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children

This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.

开始日期2015-10-01

申办/合作机构

The Children's Hospital of Philadelphia

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100 项与 DBV-135 相关的专利（医药）

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项与 DBV-135 相关的文献（医药）

2024-12-01·PEDIATRICS

Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk Versus Placebo in Children With Cow’s Milk Allergy: A Randomized Clinical Trial

Article

作者: Smith, Hunter ; Gupta, Ruchi S. ; Kan, Kristin

2024-04-01·JAMA pediatrics

Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow’s Milk Allergy

Article

作者: Fleischer, David M ; Rutault, Karine ; Bee, Katharine J ; Shreffler, Wayne G ; Wood, Robert A ; Sindher, Sayantani B ; Bégin, Philippe ; Campbell, Dianne E ; Yang, William H ; Makhija, Melanie M ; Jones, Stacie M ; Leonard, Stephanie ; Gagnon, Rémi ; Bird, J Andrew ; Sussman, Gordon L ; Chong, Hey J ; Brown-Whitehorn, Terri ; Sampson, Hugh A ; Petroni, Daniel ; Oriel, Roxanne C ; Green, Todd D ; Bois, Timothée

Importance:

No approved allergen-specific treatment exists for immunoglobulin E (IgE)–mediated cow’s milk allergy (CMA), a common childhood food allergy.

Objective:

To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin Milk in children with IgE-mediated CMA.

Design, Setting, and Participants:

A phase 1/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017. It took place at 17 trial sites in the US and Canada. Current CMA was confirmed by double-blind, placebo-controlled food challenge at study entry. Part A assessed the short-term safety of 150 μg, 300 μg, or 500 μg of Viaskin Milk; part B evaluated the efficacy and safety of the 3 doses vs placebo over 12 months of treatment. Of the 308 screened participants with physician-diagnosed CMA, 198 met eligibility criteria (including an eliciting dose 300 mg or less) and were randomized.

Intervention:

Safety of Viaskin Milk (150-μg, 300-μg, or 500-μg doses) was evaluated over a 3-week period (part A). In part B, 180 additional participants were randomized to receive Viaskin Milk at doses of 150 μg, 300 μg, or 500 μg or placebo (1:1:1:1) for 12 months.

Main Outcomes and Measures:

The primary outcome was the proportion of treatment responders, defined as a 10-fold or more increase in the cumulative reactive dose of cow’s milk protein (reaching at least 144 mg) or a cumulative reactive dose of cow’s milk protein at 1444 mg or more at the month 12 double-blind, placebo-controlled food challenge.

Results:

A total of 95.5% of the randomized participants (mean [SD] age, 8 [4.17] years; 124 of 198 were male [62.6%]) completed treatment. The highest response rate was observed in participants who received Viaskin Milk at the 300-μg dose with 24 of 49 responders (49.0%) overall vs 16 of 53 responders (30.2%) in the placebo group (odds ratio, 2.19; 95% CI, 0.91-5.41; P = .09), highest in the 2 to 11 years age group (22 of 38 [57.9%] vs 13 of 40 [32.5%]; P = .04). Most treatment-emergent adverse events were mild or moderate application-site reactions. One participant in the 500-μg Viaskin Milk dose group experienced treatment-related anaphylaxis.

Conclusions and Relevance:

In this randomized clinical trial, 12 months of daily epicutaneous immunotherapy with a dose of Viaskin Milk at 300 μg was associated with a statistically significant treatment response in 2- to 11-year-old children with IgE-mediated CMA. Treatment-related anaphylaxis and treatment-related discontinuation rates were low. Further research is needed to explore Viaskin Milk as a viable treatment option for children with IgE-mediated CMA.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02223182

2020-02-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis

Article

作者: Megan O. Lewis ; Chris A. Liacouras ; Jonathan M. Spergel ; Antonella Cianferoni ; Benjamin J. Wilkins ; Okan U. Elci ; Amanda B. Muir ; Terri Brown-Whitehorn ; Deirdre Burke

BACKGROUND & AIMS:

Eosinophilic esophagitis (EoE) is caused by an immune response to specific food allergens. There are no approved therapies beyond avoidance of the allergen(s) or treatment of inflammation. Epicutaneous immunotherapy (EPIT) reduces features of eosinophilic gastrointestinal disease in mice and pigs. We performed randomized, placebo-controlled study to determine the safety and efficacy of EPIT with Viaskin milk in children with milk-induced EoE.

METHODS:

In a double-blind study, 20 children (4-17 years old) with milk-induced EoE were randomly assigned to groups given EPIT with Viaskin milk (n = 15) or placebo (n = 5) for 9 months during a milk-free period, followed by milk-containing diet for 2 months with EPIT. Then, subjects underwent upper endoscopy analysis, biopsies were collected, and maximum esophageal eosinophil counts were determined and was the primary endpoint. After upper endoscopy, patients were given open-label EPIT for 11 months (open-label phase). The subjects were allowed to consume milk if they had maximum values of fewer than 10 eosinophils/high-power field (eos/hpf); otherwise, they remained on a milk-free diet until the last 2 months of the open-label phase.

RESULTS:

In the intent to treat population, there was no significant difference between the Viaskin milk group in mean eos/hpf (50.1 ± 43.97 eos/hpf) vs the placebo group (48.20 ± 56.98 eos/hpf). However, in the per-protocol population (7 patients given Viaskin milk and 2 patients given placebo), patients given Viaskin milk patients had a significantly lower mean eos/hpf count (25.57 ± 31.19) than patients given placebo (95.00 ± 63.64) (p = .038). At the end of the open-label phase, 9 of 19 evaluable subjects had mean values of fewer than 15 eos/hpf (47% response). The number of adverse events did not differ significantly between the Viaskin milk and placebo groups; there was 1 serious adverse event in the placebo group.

CONCLUSIONS:

In a pilot study of pediatric patients with EoE given EPIT with Viaskin milk or placebo for 11 months, we found no significant difference between groups for the maximum eosinophil count at the end of the study. However, findings from a per-protocol analysis indicate that Viaskin milk can reduce eos/hpf. At study completion, 47% of patients who continued open-label Viaskin milk for an additional 11 months had mean values of fewer than 15 eos/hpf. ClinicalTrials.gov no: NCT02579876.

项与 DBV-135 相关的新闻（医药）

2024-11-07

·Pharmaceutical Technology

DBV Technologies’ stock slides as financial woes worsens

DBV reported cash reserves of $46.4m as of 30 September, down by $92.2m it had at the end of last year. Image credit: UncleFredDesign / Shutterstock. DBV Technologies , which specialises in developing treatments for food allergies, has said that it will not have sufficient cash reserves to fund operations for “at least the next 12 months”. Noted as part of its third quarter (Q3) earnings report, the company cited operating losses and negative cash flows since the company’s inception as the reason for the low cash reserves. The French biotech’s lead candidate, peanut allergy treatment Viaskin Peanut, has till date failed to secure US regulatory approval. DBV noted that it intends to “seek additional capital as it continues research and development (R&D) efforts and prepares for the launch of Viaskin Peanut if approved.” While cautioning its investors that the company could not guarantee that it could secure financing at favourable terms, if at all. Adding DBV may need to scale back operations, by delaying or reducing its R&D operations, or may relinquish the rights to its pipeline candidates, if it fails to secure financing. DBV’s stock dropped by more than 8.17% in trading today (7 November) on the Euronext market. The company reported cash reserves of $46.4m as of 30 September, down by $92.2m from the cash on hand it had at the end of last year (31 December 2023). DBV noted that the funds were primarily directed towards clinical trial activity for Viaskin Peanut. In April 2023, the US Food and Drug Administration (FDA) stated that although DBV’s peanut allergy patch successfully met the primary endpoints in the Phase III EPITOPE trial (NCT03211247) in toddlers (aged one to three years), an additional safety study is required for approval. The Viaskin patch’s approval process has been a tumultuous one. In 2017, the allergy path failed to meet its primary endpoint in the Phase III PEPITES clinical trial (NCT02636699) in children aged 4-11 years. The company’s second attempt at Phase III VITESSE trial (NCT05741476) in a more narrowed age group of 4-7 years suffered a setback when the FDA placed a partial clinical hold on the study in September 2022. The hold has since been lifted and the company expects to share topline data from the study in Q4 2025. Following the back and forth with the FDA, DBV plans to pursue Viaskin Peanut’s approval in toddlers in the US and children aged one to seven years in Europe. LAst month, the company noted that as part of the accelerated approval pathway, the FDA requires additional safety data. DBV plans to start an additional safety study , COMFORT Toddlers, evaluating Viaskin Peanut in approximately 250 toddlers in Q2 2025. The company also plans to start a COMFORT Children, a safety study in four-to-seven-year-olds in Q2 2025. The trial is expected to enrol 250 participants. Another candidate in DBV’s pipeline is a milk allergy treatment, DBV135 (Viaskin milk patch). The company evaluated the patch in children aged two to 17 years in a Phase I/II MILES trial (NCT02223182). DBV is also investigating DVB135 as a treatment for an allergic inflammatory condition, eosinophilic esophagitis. DBV has also stated its intention to expand beyond food allergy therapies into vaccines and treatments for autoimmune and inflammatory disorders. However, these programmes are in the preclinical stage.

临床3期财报临床结果

2024-03-08

·FierceBiotech

Food allergy biotech DBV is running out of cash, with phase 3 trials underway

DBV Technologies hopes to complete enrollment in two supplemental safety trials of a peanut allergy therapy this year. DBV Technologies, a French biotech working on a treatment for food allergies, says it's running out of cash. The disclosure came via a going concern note in the company’s fourth-quarter and full-year 2023 earnings report on Friday, with DBV saying it doesn’t have enough money to keep the lights on for a full 12 months. DBV says it has until the very end of the year based on the $141.4 million in cash reported as of the end of December 2023. To persevere, the biotech will look to raise more money via debt and equity offerings. DBV’s cash reserves fell by nearly $68 million in 2023, with most of the money going toward R&D. Much of the biotech’s focus centers on lead peanut allergy treatment DBV712, with two phase 3 safety trials ongoing in kids. The goal is to complete enrollment in two supplemental six-month safety trials this year, despite experiencing delays that were attributed to new clinical trial rules in Europe. “We expect good momentum regarding Vitesse recruitment in the next several months and last subject screened by Q3 2024,” DBV CEO Daniel Tassé said in a release. The late-stage development work makes DBV’s current cash crunch all the more perilous, given how close the company potentially is to the market. In addition to wrapping up enrollment in the two COMFORT trials, DBV expects to have three-year data from an efficacy trial in toddlers 1-3 years old. A sibling trial for kids 4-7 years old is slated to screen its last patient by the third quarter of 2024. That study, named VITESSE, was previously on an FDA partial hold while the company and regulators worked on an updated trial protocol. Should DBV strengthen its balance sheet, there are two additional phase 2 trials waiting in the wings for runner-up med DBV135, which is in development for milk allergies and eosinophilic esophagitis.

临床3期临床2期

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研发状态

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
嗜酸粒细胞性食管炎	临床2期	美国	DBV Technologies SA	2015-10-01
牛奶过敏反应	临床2期	加拿大	DBV Technologies SA	2014-11-01

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临床结果

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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


NCT02223182 (MILES, CTgov)	临床1/2期	牛奶过敏反应	198	Viaskin Milk 150 mcg (Viaskin Milk 150 mcg)	範憲鑰夢鬱鹽鏇顧憲鹹(鑰衊遞憲淵構窪鏇糧憲) = 鬱鹽齋窪遞製艱糧顧糧廠鏇遞襯網衊構築夢積 (鹹醖簾鑰夢網糧簾膚壓, 範簾遞鏇齋積獵艱鹽簾 ~ 衊夢艱糧齋選鏇艱繭糧) 更多	-	2024-11-20
				Viaskin Milk 300 mcg (Viaskin Milk 300 mcg)	範憲鑰夢鬱鹽鏇顧憲鹹(鑰衊遞憲淵構窪鏇糧憲) = 範糧鹽餘鑰壓醖觸蓋壓廠鏇遞襯網衊構築夢積 (鹹醖簾鑰夢網糧簾膚壓, 網醖齋顧憲壓餘餘鏇簾 ~ 窪糧積構鏇網顧襯製製) 更多
NCT02579876 (SMILEE, CTgov)	临床2期	牛奶过敏反应 \| 嗜酸粒细胞性食管炎	20	Viaskin Milk 500 mcg (Viaskin Milk 500 mcg)	鹹膚齋壓簾繭廠廠範廠(窪網鏇艱鏇觸獵醖鏇窪) = 衊淵艱鏇壓膚淵鏇積艱觸廠範製繭鹽願衊壓餘 (積鏇製鏇簾艱艱壓齋膚, 窪網衊廠壓繭鹽餘窪觸 ~ 鬱鑰選鹽願廠夢網夢遞) 更多	-	2019-07-10
				Viaskin Placebo (Viaskin Placebo)	鹹膚齋壓簾繭廠廠範廠(窪網鏇艱鏇觸獵醖鏇窪) = 壓衊齋積積簾簾觸製鹹觸廠範製繭鹽願衊壓餘 (積鏇製鏇簾艱艱壓齋膚, 鹽窪壓繭糧餘夢蓋願遞 ~ 憲憲齋網顧衊廠範顧艱) 更多