Clinical Trials Resource Center

Dermatitis, Atopic

July 20, 2015

Anacor Pharmaceuticals reported results of two phase III studies of Crisaborole Topical Ointment, 2% (formerly AN2728) in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. The studies were multicenter, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis (defined as an Investigator’s Static Global Assessment (ISGA) score of two (mild) or three (moderate)). The ISGA is a five-point scale ranging from zero (clear) to four (severe). Patients were randomized in a 2:1 ratio (crisaborole:vehicle). Crisaborole or vehicle was applied twice daily for 28 days. Time to Success in ISGA: Time course to success in ISGA between crisaborole and vehicle was statistically significantly different (p<0.001) in each study, with patients treated with crisaborole achieving success earlier than vehicle-treated patients. Percent of patients who achieved success in the ISGA: study AD-301, (crisaborole/vehicle), N=503/256, 32.8%/25.4% (p=0.038); study AD-302, (crisaborole/vehicle), N=513/250 31.4%/18% (p<0.001). In addition to the phase III pivotal studies, the company is conducting an open-label long-term safety study to evaluate the safety of intermittent use of crisaborole for up to 12 months.

July 21, 2014

Regeneron Pharmaceuticals and Sanofi reported results of a phase IIb trial of dupilumab in adult patients with moderate-to-severe atopic dermatitis (AD). This double-blind, placebo-controlled, 16-week, dose-ranging study enrolled 380 patients. Patients were randomized to receive one of five doses of dupilumab (300mg weekly, 300mg every other week, 300mg monthly, 200mg every other week, 100mg monthly) or placebo. The follow-up period of the study is ongoing and patients will be followed for 16 weeks after treatment. The improvements in Eczema Area and Severity Index (EASI) score ranged from a high of 74% for patients in the highest dose group, who received 300mg weekly, to a low of 45% in patients who received the lowest dose of 100mg monthly, compared to 18% for patients in the placebo group (p<0.0001 for all doses). 12% to 33% of dupilumab- treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator’s global assessment (IGA) score of 0 or 1, compared to 2% with placebo (p=0.02 to p<0.0001). Dupilumab-treated patients experienced a 16.5% to 47% mean reduction in itching, as measured by the pruritus numerical- rating scale (NRS) score, compared to an increase of 5% in the placebo group (p=0.0005 to p<0.0001).

December 20, 2010

Creabilis issued positive results from a phase IIa trial of CT327 for the treatment of atopic dermatitis. This trial enrolled 15 subjects in Switzerland who received CT327 topically 0.1% cream twice daily for 15 days or placebo. A clinically significant improvement in symptoms was seen after eight days of treatment with CT327, as measured by change in mEASI (modified eczema area and severity index) score from baseline. Onset of efficacy was seen at three to five days of treatment. The greatest patient-reported benefit was in nighttime itch. CT327 was safe and well tolerated with no serious adverse events and no reported site irritation.

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