New drug trial aims to help teens with painful skin condition
NCT ID NCT06768671
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called sonelokimab in 35 teenagers aged 12 to 17 with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition that causes painful lumps. The main goals are to see how the drug moves through the body and whether it is safe. Researchers will also check if it helps reduce symptoms over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sonelokimab (a drug given as an injection under the skin)
- What this could lead to
- If it works, this could provide a new treatment option for teenagers with moderate to severe hidradenitis suppurativa.
- What could go wrong
- This is a small, early-stage study in 35 teens, so results may not apply to everyone. The drug may cause side effects or not work as well as hoped.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent. 2. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent. 3. Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III). 4. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS . 5. Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study. 6. Participants with a body weight of ≥ 40 kg. Exclusion Criteria: 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a draining fistula count of ≥20 at the Screening Visit. 3. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS. 4. Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk. 5. Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk. 6. Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS. 7. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
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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.
Contacts and locations
Locations
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Clinical Site
North Little Rock, Arkansas, 72117, United States
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Clinical Site
Stanford, California, 94304, United States
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Clinical Site
Washington D.C., District of Columbia, 20010, United States
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Clinical Site
Hollywood, Florida, 33201, United States
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Clinical Site
Miami, Florida, 33136, United States
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Clinical Site
Macon, Georgia, 31217, United States
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Clinical Site
Sandy Springs, Georgia, 30328, United States
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Clinical Site
Chicago, Illinois, 60611, United States
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Clinical Site
Columbus, Indiana, 47201, United States
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Clinical Site
Murray, Kentucky, 42071, United States
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Clinical Site
Waterford, Michigan, 48328, United States
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Clinical Site
Fargo, North Dakota, 58103, United States
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Clinical Site
Charleston, South Carolina, 29425, United States
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Clinical Site
Dallas, Texas, 75246, United States
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Clinical Site
Dallas, Texas, 75390-8575, United States
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Clinical Site
San Antonio, Texas, 78218, United States
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Clinical Site
Norfolk, Virginia, 23502, United States
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Clinical Site
Seattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an injected drug calm the painful flares of hidradenitis suppurativa?
- Nanobody drug tested against painful skin condition
- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?
- Can a pill that degrades IRAK4 tame autoimmune inflammation?
- Could childhood trauma fuel skin inflammation?