A Single-center, Prospective, Self-controlled, Observational Real-world Study of the Efficacy and Safety of Anti-IL-17A/F Monoclonal Antibody Combined With Non-ablative Dot Laser for the Treatment of Mild to Moderate Hidradenitis Suppurativa

NCT07554014 | Not Yet Recruiting Phase 4

• 1 other identifier: 2026-0222
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if combining an IL-17A/F monoclonal antibody with non-ablative fractional laser therapy works and is safe in patients with mild to moderate hidradenitis suppurativa (HS). The main questions it aims to answer are: Does the combination treatment reduce HS symptoms compared to before treatment? What are the main side effects of this combination treatment? Researchers will compare how participants feel and look after treatment to their own condition before treatment. Participants will: Get the combined treatment once every 4 weeks for 16 weeks Give skin and blood samples before the first treatment and at the last treatment visit Have a final check-up 8 weeks after the last treatment

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Laser Therapy; Antibodies, Bispecific

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving HiSCR (Hidradenitis Suppurativa Clinical Response) at Week 16

  HiSCR is defined as at least a 50% reduction from baseline in total abscess and inflammatory nodule count (AN count) and no increase from baseline in abscess or draining tunnel (fistula/sinus tract) count.

  From enrollment to the end of treatment at 16 weeks

Study Arms (1)

IL-17A/F mAb + NAFL Group

EXPERIMENTAL

Combination Product: IL-17A/F mAb + NAFL

Interventions

IL-17A/F mAb + NAFL COMBINATION_PRODUCT

Bimekizumab 120 mg + NAFL (1565 nm)

IL-17A/F mAb + NAFL Group

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participate in the study and sign the informed consent form.
• Male or female participants aged ≥ 18 years (at the time of signing the informed consent form).
• Patients with mild to moderate hidradenitis suppurativa: Hurley stage I or II.
• Participants have stable disease at screening and baseline, with lesions in ≥ 1 anatomical region and a total abscess and inflammatory nodule (AN) count ≥ 3.
• Participants must have intolerance, contraindication, or inadequate response to oral antibiotic treatment for HS for at least 3 months, or have relapsed after stopping such treatment.
• Have a basic understanding of the study purpose, the intervention, and possible side effects, and voluntarily sign the informed consent form in accordance with the spirit of the Declaration of Helsinki.
• Agree to receive regular treatment, attend follow-up visits, and undergo the required examinations and tests as specified in the clinical study protocol.

You may not qualify if:

• Known allergy to the study drug or its excipients.
• Prior use of biologics or small molecule targeted agents.
• Presence of tunnels on ultrasound at baseline; diagnosed with inflammatory diseases other than HS; history of chronic or recurrent infections; history of malignancy.
• History of drug abuse, suicide attempt, or psychiatric disorders.
• Participated in another clinical trial within the past 3 months.
• Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
• Systemic use of corticosteroids within the past 4 weeks, or topical use within the past 2 weeks.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Location

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

Jiaqi Chen

CONTACT

+86 15088687593; fatina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-03

Locations

CN (1)