Acne Inversa Clinical Study (18-70 Yrs)

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

Study Description

Brief 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)

Condition or Disease

Hidradenitis Suppruativa

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	180
Primary Outcome Measures	1. [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks
Actual Study Start Date:	May 2025
Estimated Primary Completion Date:	September 2026

Eligibility Criteria

Ages Eligible for Study:	18 – 70 years old
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Hidradenitis Supurativa

Inclusion Criteria

a. ≥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

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 candidiasisc
Unable to tolerate subcutaneous drug administration

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Hidradenitis Suppruativa Study (18-70 Years)