QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa

NCT07417917 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS12010-202
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adults With Moderate-to-severe Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (2)

• Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]

  Week 16

• Incidence and severity of treatment emergent Adverse Events [Part A]

  up to approximately 24 weeks

Study Arms (3)

QLS12010 Capsule Dose 1 Group

EXPERIMENTAL

Drug: QLS12010

QLS12010 Capsule Dose 2 Group

EXPERIMENTAL

Drug: QLS12010

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QLS12010 DRUG

QLS12010 oral capsules

QLS12010 Capsule Dose 1 Group; QLS12010 Capsule Dose 2 Group

Placebo DRUG

Matching placebo oral capsules

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Hang Li, M.D.

CONTACT

86 136 9305 8190; drlihang@126.com

Panpan Shang, M.D.

CONTACT

86 13810529592; pans_s@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02