Actively Recruiting
A Phase II, Multicenter, Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SCT650C 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
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old at the time of consent.
- Diagnosis of Hidradenitis Suppurativa based on clinical history and physical exam for at least 6 months.
- Presence of HS lesions in at least two different anatomical areas, with at least one area at Hurley Stage II or III at screening and baseline.
- Moderate to severe HS defined as at least 5 inflammatory lesions at screening and baseline.
- History of inadequate response, intolerance, or contraindication to systemic antibiotics for HS.
- Agreement to daily use of specified topical antiseptics on affected areas during the study.
- If on systemic antibiotics, must be on a stable dose for at least 4 weeks before baseline and expected to remain stable for 16 weeks.
- Female participants must be not of childbearing potential or willing to use effective contraception as specified; males with partners of childbearing potential must use condoms.
- Signed informed consent form approved by an ethics committee.
You will not qualify if you...
- Medical or psychiatric conditions that could interfere with participation.
- Draining fistula count greater than 20 at baseline.
- Other active skin diseases that may interfere with HS assessment.
- Diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease.
- Primary immunosuppressive conditions or immunosuppressive therapy.
- Pregnant, breastfeeding, or planning pregnancy during or shortly after the study.
- Recent or chronic infections, including tuberculosis, hepatitis B or C, HIV, or syphilis.
- History or current malignancy within 5 years, except certain treated skin or cervical cancers.
- History of lymphoproliferative disorders.
- Major surgery within 3 months prior or planned during the study.
- Uncontrolled or unstable systemic diseases.
- Recent heart attack or stroke within 6 months.
- History of substance abuse or depression with suicidal behavior.
- Known allergy to SCT650C components.
- Recent exposure to certain biologic or immunomodulatory therapies as specified.
- Use of traditional medicines or herbal remedies within 28 days before baseline.
- Recent use of non-allowable topical or systemic therapies for HS.
- Recent use of live vaccines within 8 weeks before treatment.
- Participation in other investigational drug studies within 30 days before treatment.
- Laboratory abnormalities outside specified limits.
- Estimated kidney function below specified threshold.
- Employment or immediate family employment related to the study or sponsor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants receive initial doses of SCT650C or placebo administered subcutaneously during this period.
Multiple visits for initial dosing at specified intervals
Duration - Up to 48 weeks
Participants continue receiving SCT650C or placebo subcutaneously at specified intervals to maintain treatment effect.
Multiple visits for ongoing dosing and assessments
Trial Site Locations
Total: 1 location
1
Ondokuz Mayis University Medical Faculty
Samsun, Turkey, Turkey (Türkiye), 55200
Actively Recruiting
Research Team
M
Miaomiao Zhang, PhD
M
Müge Güler Özden, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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