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QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa

NCT07417917 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-18

No results posted yet for this study

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

Interventions

DRUG

QLS12010

QLS12010 oral capsules

DRUG

Placebo

Matching placebo oral capsules

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-06-01
Completion
2028-05-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417917 on ClinicalTrials.gov