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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • IL-17A/F mAb + NAFL

    Combination product

    Bimekizumab 120 mg + NAFL (1565 nm)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: IL-17A/F mAb + NAFL GroupExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: