Clinical Trials Resource Center

Allergy (Pediatric)

October 12, 2015

DBV Technologies has announced results of Viaskin Peanut for peanut allergy. OLFUS is an ongoing, open-label, follow-up study to VIPES, the company’s phase IIb clinical trial with Viaskin Peanut. OLFUS enrolled 171 subjects who previously had received either placebo or one of three 12-month dose regimens administered during VIPES. During the first year of OLFUS, patients were to receive a daily application of Viaskin Peanut 50μg, Viaskin Peanut 100μg or Viaskin Peanut 250μg for 12 months. Baseline response levels in OLFUS were based on the results of the last double-blind, placebo controlled food challenge (DBPCFC) in VIPES, and adjusted by the number of patients enrolling in OLFUS. As in VIPES, a responder in the OLFUS trial was defined as a subject who could reach a peanut protein eliciting dose equal to or greater than 1,000mg peanut protein during the 12-month DBPCFC or a subject with a ≥10-fold increase of the eliciting dose compared to the initial eliciting dose after 12 months of treatment. Patients enrolled in OLFUS who received placebo in VIPES were analyzed separately from subjects who initially received Viaskin Peanut. During the first 12 months of OLFUS, no drug-related epinephrine use or serious adverse events (SAEs) due to Viaskin Peanut were reported. The study’s median compliance rate, which was maintained at 96%, also was consistent with previously reported results. A preliminary analysis of the OLFUS data showed that 12 additional months of therapy with Viaskin Peanut 250μg increased the number of patients benefiting from treatment to 70% in OLFUS from 50% in VIPES, with 80% of children (ages 6 to 11 at entry in VIPES) responding to therapy after 24 months. Patients who received placebo for one year in VIPES and received Viaskin Peanut for 12 months in OLFUS showed a 50% response rate, which was consistent with findings from VIPES. DBV expects to launch its phase III Viaskin Peanut trial at 35 sites in North America, Australia, Ireland and Germany in the fourth quarter. DBV also is in the development process for other Viaskin treatments, such as its treatment currently being trialed for milk.

June 15, 2015

Aimmune Therapeutics reported results of a phase II study of AR101 for the treatment of peanut allergy. The study, conducted at eight U.S. sites, evaluated 23 patients ages four to 21 who failed a double-blind, placebo-controlled food challenge of less than or equal to 100mg of peanut protein. The randomized, double-blind, placebo-controlled study had 55 patients in the intent-to-treat population, with 29 in the active group and 26 in the placebo group. The active arm had six early discontinuations due to gastrointestinal side effects and compliance issues. All patients who completed the active treatment regimen met the primary endpoint of tolerating a cumulative amount of peanut protein of at least 443mg, compared to five of 26 patients receiving placebo (p≤0.0001). Additionally, 18 of 23 patients who completed the active treatment regimen tolerated a cumulative amount of peanut protein of at least 1,043mg, compared to zero of 26 patients receiving placebo (p≤0.0001). AR101 has been granted Fast Track designation by the FDA. Aimmune Therapeutics plans to initiate a phase III registration trial of AR101 in children and adults.

September 29, 2014

DBV Technologies has reported results of a phase IIb trial of Viaskin Peanut in peanut allergic patients. In the double-blind, placebo-controlled, multicenter trial, 221 patients highly allergic to peanut were randomized to either a 50μg, 100μg or 250μg peanut protein dose of Viaskin Peanut versus placebo. The trial was prospectively organized across the three dose levels with two patient strata composed of three different patient age groups: children (113 subjects ages 6-11) for the first stratum; and adolescents (73 subjects ages 12-17) plus adults (35 subjects ages 18-55) for the other stratum. All patients received a daily application of the Viaskin Peanut patch over a 12-month treatment period. A total of 56 patients were randomized to the Viaskin Peanut 250μg dose. In this arm, 50% of patients responded, compared to 25% in the placebo group, showing statistical significance (p=0.0108). Adolescents showed a trend toward efficacy, showing a response rate of 38.9% in the active arm v. 22.2% in the corresponding placebo group. A statistically significant improvement in the adolescents’ ability to consume peanut protein also was observed, as the LS mean in change of CRD versus placebo of this subgroup was 276mg (p=0.047). The IgG4 increase observed in adolescents, a 3.3 fold increase over 12 months, suggests the beginning of a successful desensitization process.

July 5, 2004

Dynavax Technologies and UCB Pharma have reported positive results of their phase I pediatric trial of AIC, their investigational ragweed allergy vaccine. Results have indicated that the drug is well tolerated in children and adolescents. The dose-escalating, open-label study enrolled 24 children between the ages of 9 and 17, all of whom had documented ragweed allergy; subjects were divided into three dosing cohorts, which each received increasing doses of AIC. Overall safety and tolerability were excellent, with only minor, localized, injection-site reactions reported and no serious adverse incidents. Based on these data, the companies announced plans to extend their clinical investigations into the use of AIC as a prophylactic against ragweed-allergy-induced sequelae, including asthma and chronic sinusitis.

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