RECRUITING

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06993610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, 18 to 70 years of age
  2. * ≥6-month history of Hidradenitis suppurativa (HS)
  3. * Total AN (abscesse and inflammatory nodule) count ≥5
  4. * HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
  1. * Draining tunnel count \>20
  2. * Presence of another inflammatory condition or a skin condition that may interfere with study assessments
  3. * Known to have immune deficiency or is immunocompromised
  4. * Evidence or suspicion of active or latent tuberculosis
  5. * 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
  6. * Has active systemic candidiasis
  7. * Unable to tolerate subcutaneous drug administration

Contacts and Locations

Study Contact

Chief Medical Officer
CONTACT
702-825-9872
clinicaltrial@zurabio.com

Study Locations (Sites)

DelRicht LLC
Baton Rouge, Louisiana, 70809
United States

Collaborators and Investigators

Sponsor: Zura Bio Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-05
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Hidradenitis Suppurativa
  • HS
  • Tibulizumab
  • Hidradenitis Suppurativa clinical response
  • HiSCR
  • Skin Diseases
  • Inflammatory Skin Disease
  • Chronic Skin Condition
  • Sweat Gland Disease
  • Skin Diseases Bacterial
  • Suppurative Hidradenitis
  • Hidradenitis
  • Acne
  • Acne inversa
  • Inversa

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa (HS)