QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa

February 11, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa

This is a Phase II clinical study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of QLS12010 capsules in the treatment of moderate to severe Hidradenitis Suppurativa (HS). The study is comprised of two parts: Part A is a multi-center, open-label, single-dose group proof-of-concept study; Part B is a randomized, double-blind, placebo-controlled dose-ranging study. The overall duration of this study is up to 32 weeks, inclusive of the Screening Period, Treatment Period of up to 24 weeks, and the 4-Week Follow-Up Period for safety assessment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Panpan Shang, M.D.
  • Phone Number: 86 13810529592
  • Email: pans_s@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At screening, the diagnosis of Hidradenitis suppurativa (HS), with a duration of HS ≥ 6 months;
  • Have moderately to severely active HS at Screening and baseline

  • According to the assessment of the Investigators, one of the following medical histories exists:

    1. Regular systemic antibiotic treatment for HS has been ineffective.
    2. The patient is intolerant to or has contraindications for systemic antibiotic treatment for HS.

Exclusion Criteria:

  • Participants has a fistulas/sinus tracts (active and inactive) >20 at Screening or Baseline；
  • History of severe cardiovascular and cerebrovascular diseases occurring within 6 months prior to screening, including but not limited to unstable angina pectoris, New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, cardiomyopathy, cerebral hemorrhage, acute cerebral infarction, etc.;
  • Participants with a history of prior use of Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) degraders, small-molecule IRAK4 inhibitors, or similar agents;
  • Participants who have received treatment with other investigational products (IPs) within 3 months or 5 half-lives (whichever is longer) prior to screening;
  • Pregnant or lactating women, or participants with a positive pregnancy test result at screening;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Drug: Placebo
Matching placebo oral capsules
Experimental: QLS12010 Capsule Dose 1 Group
Drug: QLS12010
QLS12010 oral capsules
Experimental: QLS12010 Capsule Dose 2 Group
Drug: QLS12010
QLS12010 oral capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]
Time Frame: Week 16
Week 16
Incidence and severity of treatment emergent Adverse Events [Part A]
Time Frame: up to approximately 24 weeks
up to approximately 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • QLS12010-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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