A Single-center, Prospective, Self-controlled, Observatio... | NCT07554014

Studies
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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Not yet recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Hidradenitis Suppurativa (HS)

Interventions

IL-17A/F mAb + NAFL

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Apr 21, 2026

First Submission Date that Met QC Criteria

Apr 21, 2026

First Posted Date

Apr 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
IL-17A/F mAb + NAFL Group	Experimental		Combination Product: IL-17A/F mAb + NAFL

Name	Type	Description	Arm Group Labels	Other Names
IL-17A/F mAb + NAFL	Combination Product	Bimekizumab 120 mg + NAFL (1565 nm)	IL-17A/F mAb + NAFL Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious
D013492	Suppuration
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D016575	Hidradenitis
D013543	Sweat Gland Diseases