RecruitingPhase 2

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

Turkey (Türkiye)60 participantsStarted 2025-12-16

Plain-language summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The participants must be at least 18 years of age at the time of signing the ICF.
✓. Study participants must have a diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the baseline visit; diagnosis must be verifiable through medical notes and documentation.
✓. Study participants must have HS lesions in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
✓. Study participants must have moderate to severe HS defined as a total of ≥ 5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits.
✓. Study participants must have had a history of inadequate response, intolerance or contraindication to a course of systemic antibiotics for treatment of HS at the Screening Visit as assessed by the investigator.
✓. Participants agree to daily use of topical antiseptics on the areas affected by HS lesions while on study treatment. Allowable antiseptic washes are limited to one of the following: chlorhexidine gluconate, benzoyl peroxide, benzalkonium chloride, benzethonium chloride, or dilute bleach in bath water.
✓. Participants entering the study while undergoing concomitant treatment with systemic antibiotics (as specified in the protocol) must be on a stable dose. A stable dose is defined as a dosage or regimen that has remained unchanged for at least four weeks prior to baseline and is expected to remain unchanged for at least the first 16 weeks of the study.
✓. Female participants must be not of childbearing potential or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception up to 40 weeks after the last administration of the investigational medical product (IMP) and have a negative pregnancy test prior to the first dose. The following methods are considered highly effective when used consistently and correctly:

Exclusion criteria

✕. Study participant has any medical or psychiatric condition could jeopardize or would compromise the study participant's ability to participate in this study as determined by the investigator based on protocol-required assessments.
✕. Study participant has a draining fistula count of \> 20 at the Baseline Visit.
✕. Study participant has any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS.
✕. Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).
✕. Study participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a splenectomy.
✕. Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 40 weeks following the final dose of IMP.
✕. Study participant has an active infection or history of infection(s) as follows:
✕. Study participant has any of the following (for more information, refer to Section 9.2):

What they're measuring

The percentage of participants achieving HiSCR75 (a 75% reduction from baseline of Hidradenitis Suppurativa Clinical Response [HiSCR]) at Week 16

Timeframe: Week 16

Trial details

NCT IDNCT07244510

SponsorSinocelltech Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-12

Contact for this trial

Miaomiao Zhang, PhD

17628293460 miaomiao_zhang@sinocelltech.com

View on ClinicalTrials.gov More Hidradenitis Suppurativa (HS) trials