CliniExperts Research Services Mentioned at EADV Annual Conference in Berlin

CliniExperts Research Services has helped Legacy Healthcare in implementing efficacy and safety study of Coacillium in the Indian sites of the trial. The contribution to this study was duly mentioned at the EADV Annual Conference in Berlin, and we are proud and humbled in equal measure at this mention.

CliniExperts Research Services has helped Legacy Healthcare in implementing Liberty Healthcare’s Coacillium Phase 2-3 Trial Outcomes in the Indian sites.

- CliniExperts Research

December 05, 2023

Legacy Healthcare, Switzerland, the sponsor of the study on efficacy and safety of Coacillium in children and adolescents with moderate to severe Alopecia Areata (AA), presented the phase 2-3 trial results at the European Academy of Dermatology and Venereology (EADV) Congress held in Berlin between 11^th and 14^th October, 2023. CliniExperts Research Services has helped Legacy Healthcare in implementing this study in the Indian sites of the trial. As such, our contribution to this study was duly mentioned at the Congress, and we are proud and humbled in equal measure at this mention.

Role of Legacy Healthcare in the study

Headquartered in Epalinges, Switzerland, the company leads global initiatives in transformative research for chronic autoimmune and inflammatory diseases. This particular study is key to Legacy Healthcare’s forays in future AA treatments, starting with children and adolescents.

Key aspects of the study

The study investigated the efficacy and safety of Coacillium* in children and adolescents with moderate to severe AA. A randomised, double-blind, multicentre, phase 2–3 trial, RAAINBOW, was conducted at 12 sites in 4 countries. Patients aged >2 to <18 years with Severity of Alopecia Tool (SALT) score of 25-50 (moderate AA) and 50-95 (severe AA) were randomly assigned to a twice-daily dose of Coacillium cutaneous solution 22.25% (Coacillium group), or placebo (placebo group)(2:1). The trial design tenure was 24 weeks, and this was followed by a treatment-free period of 24 weeks to evaluate disease relapse after treatment discontinuation. No concomitant treatment for AA was allowed. For the benefit of interested stakeholders, trial details are registered with ClinicalTrials.gov, NCT03240627.

Outcomes

A total of 107 patients were randomly assigned to Coacillium (71) or placebo (36). The average age was 11 years old, mean time since onset of disease was 3 years, 45% were female, 60% had severe AA, 40% moderate AA, 52% experienced their first episode of AA and 48% their second flare or more. The primary endpoint was the relative change in SALT score. After 24 weeks of treatment, the average change in Coacillium group (+22.87%) was statistically significantly superior to the placebo group (-8.00%) (p<0.0001). In the Coacillium group, 82% experience hair growth after treatment discontinuation of the treatment during the 24 weeks treatment-free period.. At the end of the trial, including 24 weeks without treatment, the percentage of patients with a SALT score of 20 or less was 46.7% in Coacillium group and 9.1% in the placebo (p=0.0031). Improvement of CDLQI was consistent with treatment effect; at week 48, CDLQI change in Coacillium group was -2.52 while change in placebo group was +0.83 (p=0.0313). No serious adverse event was reported in the Coacillium group. One case of severe transient eczema was reported, while all other AEs were mild or moderate, local and transient.

Trial summary

This phase 2-3 trial involving children and adolescents with moderate to severe AA, Coacillium cutaneous solution 22.25% of twice-daily dose proved to be significantly superior to treatment with placebo after 24 weeks of treatment. It was well tolerated as well. Most Coacillium-treated subject experiences hair growth after treatment discontinuation. In summary, Coacillium cutaneous solution 22.25% may be a suitable treatment regimen for the 2-18 years’ patient group reporting moderate to severe AA.

Access Legacy Healthcare’s complete EADV presentation here:

http://legacyhealthcare.ch/fichiers/EADV-2023-Coacillium-Ph-2-3-trial-late-breaking-news-pres-Oct-112023.pdf