RECRUITING

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

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)

Conditions

Hidradenitis Suppurativa (HS)
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Related Conditions:

Hidradenitis Suppurativa (HS)

Study Overview

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Study Details

Study overview

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)

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

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

Condition
Hidradenitis Suppurativa (HS)
Intervention / Treatment

-

Contacts and Locations

Baton Rouge

DelRicht LLC, Baton Rouge, Louisiana, United States, 70809

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female, 18 to 70 years of age
  • * ≥6-month history of Hidradenitis suppurativa (HS)
  • * Total AN (abscesse and inflammatory nodule) count ≥5
  • * HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zura Bio Inc,

Study Record Dates

2027-03