Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06444451
Brief Summary:
This is a parallel, Phase 2 multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study to investigate the efficacy and safety of subcutaneous (SC) injections of amlitelimab treatment as monotherapy in participants aged 18 years and older with severe alopecia areata (AA). At the end of the double-blind treatment period, all participants will have the option to enter the open-label extension (OLE) period.
The study duration will be up to 160 weeks for participants entering the OLE period including a 2-to-4-week screening, a 36-week randomized double-blind period, an optional OLE period (104 weeks) and a 16-week safety follow-up. The open-label extension period is optional and open to all participants who have completed the double-blind treatment period.
The total number of visits will be up to 38 visits (or 12 visits for those not entering the OLE study).
Study:
NCT06444451
Study Brief:
Protocol Section:
NCT06444451