Actively Recruiting
Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa
Led by Sinocelltech Ltd. · Updated on 2026-04-28
60
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa
CONDITIONS
Official Title
Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at time of informed consent
- Diagnosed with Hidradenitis Suppurativa for at least 6 months confirmed by medical records
- HS lesions in at least 2 distinct anatomical areas, with at least one area at Hurley Stage II or III
- Moderate to severe HS defined as 5 or more inflammatory lesions at screening and baseline
- History of inadequate response, intolerance, or contraindication to systemic antibiotics for HS
- Agree to daily use of specified topical antiseptics on affected areas during study
- If on systemic antibiotics, must be on stable dose for at least 4 weeks prior to baseline and expected to remain stable through 16 weeks
- Female participants must be not of childbearing potential or use highly effective contraception up to 40 weeks after last dose, with negative pregnancy test before first dose
- Male participants with partners of childbearing potential must use condoms until 40 weeks after last dose
- Signed and dated informed consent form approved by IRB/IEC
You will not qualify if you...
- Any medical or psychiatric condition compromising ability to participate
- Draining fistula count over 20 at baseline
- Other active skin diseases interfering with HS assessment
- Diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease
- Primary immunosuppressive condition or immunosuppressive therapy post-organ transplant or splenectomy
- Breastfeeding, pregnant, or planning pregnancy during study or within 40 weeks after last dose
- Active or recent infection requiring systemic treatment within 28 days prior to baseline or history of opportunistic/recurrent/chronic infections
- Active tuberculosis, latent TB, high risk for TB, or nontuberculous mycobacterial infection
- Acute or chronic hepatitis B, hepatitis C, HIV infection, or positive treponema pallidum antibody
- Current or recent malignancy except certain treated skin or cervical cancers
- History or signs of lymphoproliferative disorders
- Major surgery within 3 months prior to baseline or planned during study
- Uncontrolled or unstable systemic disease
- Myocardial infarction or stroke within 6 months prior to screening
- History of chronic alcohol or drug abuse within 6 months prior to screening
- History of depression or suicidal thoughts deemed unsuitable
- Known hypersensitivity to SCT650C excipients
- Prior exposure to specified biologic therapies within defined timeframes
- Use of traditional/herbal medicines within 28 days prior to baseline
- Recent non-allowable topical or systemic therapies for HS
- Recent use of oral analgesics including opioids unless stable non-opioid regimen
- Receipt of live vaccine within 8 weeks prior to first dose or expected need during study
- Participation in another investigational drug study within 30 days or 5 half-lives
- Laboratory abnormalities exceeding set thresholds at screening
- Estimated glomerular filtration rate below 60 mL/min/1.73m2
- Employment or immediate family relation to study sponsor or site staff
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Müge Güler Özden, MD
CONTACT
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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