New pill could ease painful skin condition for those failed by antibiotics

NCT ID NCT07417917

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase II trial tests QLS12010, an oral capsule, in 102 adults with moderate-to-severe hidradenitis suppurativa (HS), a painful skin condition. The study has two parts: an open-label proof-of-concept phase and a placebo-controlled dose-ranging phase. Participants must have tried and failed or been unable to take antibiotics for HS. The goal is to see if the drug reduces abscesses and inflammatory nodules safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QLS12010 capsules
What this could lead to
If successful, this could lead to a new oral treatment option for people with moderate-to-severe hidradenitis suppurativa who haven't responded to antibiotics.
What could go wrong
This is an early Phase II trial with only 102 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 102 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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