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OpenTrials
Active, Not Recruiting

NCT Number: NCT06993610

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hidradenitis Suppurativa (HS) Acne Vulgaris Acneiform Eruptions Bacterial Infections Bacterial Infections and Mycoses Dermatitis Hidradenitis Hidradenitis Suppurativa Infections Sebaceous Gland Diseases Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ryan Clinical Research Inc., Newmarket, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibulizumab Dose A

Biological

Anti BAFF/IL-17 antibody. ZB-106

Tibulizumab Dose B

Biological

Anti BAFF/IL-17 antibody. ZB-106

Placebo

Other

ZB-106 Placebo

Primary outcomes

  1. [Period 1] Percent change from baseline in abscess and inflammatory nodule (AN) count at 16 weeks

    Time frame: Week 16

    AN count is calculated based on the sum of the abscesses and inflammatory nodules across different anatomical areas

Secondary outcomes

  1. [Period 1] Achieving HiSCR50 at Week 16

    Time frame: Week 16

    HiSCR50 is defined as at least a 50% decrease in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count

  2. [Period 1] Achieving HiSCR75 at Week 16

    Time frame: Week 16

    HiSCR75 is defined as at least a 75% decrease in total abscess and inflammatory nodule (AN) count with no increase from baseline in abscess and/or draining fistula count

  3. [Period 1] Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16

    Time frame: Week 16

    The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each item uses a scale from 0 (not at all) to 3 (very much), with a total score being the sum of each question. The higher the total score the more a patient's life is affected by their skin condition.

  4. [Period 1] Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16

    Time frame: Week 16

    The HS-PtGA is a single item measure that asks the individual to rate the overall impact of HS on their quality of life, capturing their comprehensive perception of disease severity and treatment response.

  5. [Period 1] Absolute change from baseline in Skin Pain Numeric Rating Scale (NRS) at Week 16

    Time frame: Week 16

    The Skin Pain NRS is a single-item measure in which the participant rates the worst level of skin pain in the previous 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable).

  6. [Period 1] Safety and tolerability of tibulizumab

    Time frame: Week 16

    Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results.

Sponsors and collaborators

Lead sponsor

Zura Bio Inc

Industry

Registry information

Official study 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

Acronym: TibuSHIELD

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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