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New drug trial aims to help teens with painful skin condition

NCT ID NCT06768671

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 35 people

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

Started

Dec 2024

Expected to finish

Sep 2026

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

12 to 17 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: 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

  • Clinical Site

    North Little Rock, Arkansas, 72117, United States

  • Clinical Site

    Stanford, California, 94304, United States

  • Clinical Site

    Washington D.C., District of Columbia, 20010, United States

  • Clinical Site

    Hollywood, Florida, 33201, United States

  • Clinical Site

    Miami, Florida, 33136, United States

  • Clinical Site

    Macon, Georgia, 31217, United States

  • Clinical Site

    Sandy Springs, Georgia, 30328, United States

  • Clinical Site

    Chicago, Illinois, 60611, United States

  • Clinical Site

    Columbus, Indiana, 47201, United States

  • Clinical Site

    Murray, Kentucky, 42071, United States

  • Clinical Site

    Waterford, Michigan, 48328, United States

  • Clinical Site

    Fargo, North Dakota, 58103, United States

  • Clinical Site

    Charleston, South Carolina, 29425, United States

  • Clinical Site

    Dallas, Texas, 75246, United States

  • Clinical Site

    Dallas, Texas, 75390-8575, United States

  • Clinical Site

    San Antonio, Texas, 78218, United States

  • Clinical Site

    Norfolk, Virginia, 23502, United States

  • Clinical Site

    Seattle, Washington, 98105, United States

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