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NCT Number: NCT07554014

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Hangzhou, Zhejiang, China

Location contact

Jiaqi Chen

CONTACT

[email protected]

+86 15088687593

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Any other condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion.
  • Systemic use of corticosteroids within the past 4 weeks, or topical use within the past 2 weeks.

Treatment and study plan

IL-17A/F mAb + NAFL

Combination Product

Bimekizumab 120 mg + NAFL (1565 nm)

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaqi Chen

CONTACT

[email protected]

+86 15088687593

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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