Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (NCT06993610) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense
United States, Canada, Germany225 participantsStarted 2025-05-16
Plain-language summary
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18 to 70 years of age
* ≥6-month history of Hidradenitis suppurativa (HS)
* Total AN (abscess and inflammatory nodule) count ≥5
* HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
Exclusion Criteria:
* Draining tunnel count \>20
* Presence of another inflammatory condition or a skin condition that may interfere with study assessments
* Known to have immune deficiency or is immunocompromised
* Evidence or suspicion of active or latent tuberculosis
* History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks
* Has active systemic candidiasis
* Unable to tolerate subcutaneous drug administration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
[Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks