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Phase 2
Age: 18Years +
All Genders
ID07244510

Phase II Study to Evaluate Safety and Effectiveness of SCT650C Injection in Adults With Moderate to Severe Hidradenitis Suppurativa

Led by Sinocelltech Ltd. · Updated on 2026-04-28

60

Participants Needed

1

Research Sites

48 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, pharmacokinetics, and immune response of a drug called SCT650C in adults with moderate to severe Hidradenitis Suppurativa HS, a chronic skin condition. This Phase II, multicenter, double-blinded, placebo-controlled trial aims to better understand how SCT650C works and its impact on this condition. The study plans to involve up to 60 participants divided into three groups based on dosage and placebo use. Participants will be randomly assigned to receive either a high dose or low dose of SCT650C, or a placebo, administered subcutaneously under the skin. The study consists of three periods a screening period to determine eligibility, a loading period when the initial doses are given, and a maintenance period for ongoing treatment. Doses are given multiple times at specified intervals throughout the study. During the study, participants will undergo various assessments including measuring skin lesion reductions using the HiSCR75 scale at Week 16 and Week 48, evaluations of disease severity, skin pain, and quality of life. Safety is monitored through reports of adverse events and laboratory tests. Drug levels and immune response markers will also be tracked. The total participation time spans from screening through Week 48 of treatment evaluation.

CONDITIONS

Brief Title

Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa

Research Team

M

Miaomiao Zhang, PhD

M

Müge Güler Özden, MD

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