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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • SCT650C

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators