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

NCT07244510 | Recruiting Phase 2

• 1 other identifier: SCT650C-D201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

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

  HiSCR75 is defined as at least a 75 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count.

  Week 16

Secondary Outcomes (10)

• The percentage of participants achieving HiSCR50, HiSCR90, and HiSCR100 at specified time points

  Week 48

• The percentage of participants achieving HiSCR75 at specified time points

  Week 48

• The percentage of participants who experience ≥ 1 disease flare at specified time points

  Week 48

• The change from baseline in the HS-Physician's Global Assessment (HSPGA) at specified time points

  Week 48

• The change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at specified time points

  Week 48

Study Arms (3)

SCT650C high dose Group /Group 1

ACTIVE COMPARATOR

SCT650C high dose s.c. multiple doses at specified intervals

Drug: SCT650C

SCT650C low dose Group /Group 2

ACTIVE COMPARATOR

SCT650C low dose s.c., multiple doses at specified intervals

Drug: SCT650C

Placebo Group /Group 3

PLACEBO COMPARATOR

Placebo / SCT650C high or low dose s.c., multiple doses at specified intervals

Drug: SCT650C

Interventions

SCT650C DRUG

Administered SC

Also known as: Recombinant anti-IL-17A antibody

Placebo Group /Group 3; SCT650C high dose Group /Group 1; SCT650C low dose Group /Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
• combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
• intrauterine device (IUD);
• intrauterine hormone-releasing system (IUS);
• bilateral tubal occlusion;
• vasectomized partner (where postvasectomy testing had demonstrated sperm clearance);
• Sexual abstinence if it is in accordance with a participant's preferred and common lifestyle.

You may not qualify if:

• 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:
• Any infection requiring systemic treatment within 28 days prior to Baseline;
• A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant.
• Opportunistic infections are infections caused by uncommon pathogens (eg, Pneumocystis jirovicii, cryptococcosis), or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster).
• Study participant has any of the following (for more information, refer to Section 9.2):
• Known active tuberculosis (TB) disease;
• History of active TB involving any organ system unless adequately treated according to World Health Organization/ Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consult with a TB specialist.
• Latent TB infection (LTBI).
• High risk of acquiring TB infection.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Ondokuz Mayis University Medical Faculty

Samsun, Turkey, 55200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Miaomiao Zhang, PhD

CONTACT

17628293460; miaomiao_zhang@sinocelltech.com

Müge Güler Özden, MD

CONTACT

905324068600; mgulerozden@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): February 16, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

TU (1)