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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Combination product: IL-17A/F mAb + NAFL

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiaqi Chen; Phone Number: +86 15088687593; Email: fatina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Jiaqi Chen; Phone Number: +86 15088687593; Email: fatina@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients voluntarily participate in the study and sign the informed consent form.
2. Male or female participants aged ≥ 18 years (at the time of signing the informed consent form).
3. Patients with mild to moderate hidradenitis suppurativa: Hurley stage I or II.
4. Participants have stable disease at screening and baseline, with lesions in ≥ 1 anatomical region and a total abscess and inflammatory nodule (AN) count ≥ 3.
5. 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.
6. 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.
7. Agree to receive regular treatment, attend follow-up visits, and undergo the required examinations and tests as specified in the clinical study protocol.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IL-17A/F mAb + NAFL Group	Combination product: IL-17A/F mAb + NAFL; Bimekizumab 120 mg + NAFL (1565 nm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Laser Therapy; Antibodies, Bispecific
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: 2026-0222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No