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Evaluating tibulizumab for treating hidradenitis suppurativa

A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Hidradenitis Suppurativa

Phase 2 Interventional Zura Bio Inc · NCT06993610

This study is testing if a new medication called tibulizumab can help adults with hidradenitis suppurativa improve their skin and reduce inflammation over 16 weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorZura Bio Inc Industry-sponsored
Drugs / interventionstibulizumab
Locations56 sites (Phoenix, Arizona and 55 other locations)
Trial IDNCT06993610 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is designed to assess the effectiveness of tibulizumab in adults suffering from hidradenitis suppurativa over a 16-week period, followed by an additional 16-week open-label extension where all participants will receive the treatment. The study is randomized and double-blind, ensuring that neither the participants nor the researchers know who receives the active drug versus a placebo during the initial phase. The trial aims to measure the clinical response to tibulizumab, focusing on skin healing and inflammation reduction.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a history of hidradenitis suppurativa and a significant number of abscesses and inflammatory nodules.

Not a fit: Patients with draining tunnels exceeding 20 or those with other inflammatory skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with hidradenitis suppurativa by reducing symptoms and promoting skin healing.

How similar studies have performed: Previous studies have shown promise in treating hidradenitis suppurativa with similar biologic approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaHSTibulizumabHidradenitis Suppurativa clinical responseHiSCRSkin DiseasesInflammatory Skin DiseaseChronic Skin Condition
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.