Adults With Moderate-to-severe Hidradenitis SuppurativaPhase 2NCT07417917
QLS12010 Capsules in Adults With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing QLS12010 in people with Adults With Moderate-to-severe Hidradenitis Suppurativa, run by Qilu Pharmaceutical Co., Ltd..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adults With Moderate-to-severe Hidradenitis Suppurativa
- What is being tested?
- QLS12010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- QLS12010, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS12010Drug
QLS12010 oral capsules
PlaceboDrug
Matching placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| QLS12010 Capsule Dose 1 Group | Experimental | Not described Receives: Drug: QLS12010 |
| QLS12010 Capsule Dose 2 Group | Experimental | Not described Receives: Drug: QLS12010 |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]
Measured: Week 16
Incidence and severity of treatment emergent Adverse Events [Part A]
Measured: up to approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Moderate-to-severe Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417917
- Sponsor's protocol ID
- QLS12010-202
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07417917
- Acronym / sponsor ID
- QLS12010-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QLS12010 Capsule Dose 1 Group | Experimental | Drug: QLS12010 |
| QLS12010 Capsule Dose 2 Group | Experimental | Drug: QLS12010 |
| Placebo Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS12010QLS12010 oral capsules | Drug | QLS12010 Capsule Dose 1 Group, QLS12010 Capsule Dose 2 Group |
| PlaceboMatching placebo oral capsules | Drug | Placebo Group |
Primary outcome
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B]
Time frame: Week 16
Incidence and severity of treatment emergent Adverse Events [Part A]
Time frame: up to approximately 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS12010 in people with Adults With Moderate-to-severe Hidradenitis Suppurativa, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang Li, M.D. (86 136 9305 8190, drlihang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change form Baseline in a total abscess and inflammatory nodule(AN) count [Part B] (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.