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Hidradenitis Suppurativa (HS)Phase 2TibuSHIELDNCT06993610

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense

A Phase 2 study testing Tibulizumab Dose A and Tibulizumab Dose B in people with Hidradenitis Suppurativa (HS), run by Zura Bio Inc at 61 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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) Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
Tibulizumab Dose A and Tibulizumab Dose B
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
61 sitesin 6 countries
Study dates
16 May 2025to Apr 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

61 sites in 6 countries.

61 sites in 6 countries

United States34 sites

  • Palmetto Clinical Trial Services

    Anderson, South Carolina, 29625

  • DelRicht LLC

    Baton Rouge, Louisiana, 70809

  • Optima Research

    Boardman, Ohio, 44512

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Equity Medical LLC (Kentucky)

    Bowling Green, Kentucky, 42104

  • Best Skin Research LLC

    Camp Hill, Pennsylvania, 17011

  • ClinOhio Research Services

    Columbus, Ohio, 43213

  • Florida Academic Dermatology Center

    Coral Gables, Florida, 33134

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Red River Research Partners

    Fargo, North Dakota, 58103

  • Skin Care Research, LLC

    Hollywood, Florida, 33021

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • First OC Dermatology Research, Inc.

    Irvine, California, 92614

  • BRCR Global Texas

    Katy, Texas, 77450

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056

  • DS Research of Kentucky, LLC

    Louisville, Kentucky, 40241

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Frontier Dermatology

    Mill Creek, Washington, 98012

  • DelRicht Research

    Mt. Pleasant, South Carolina, 29464

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130

  • Equity Medical

    New York, New York, 10023

  • OptiSkin Medical

    New York, New York, 10128

  • Northridge Clinical Trials

    Northridge, California, 91325

  • Medical Dermatology Specialists (Phoenix)

    Phoenix, Arizona, 85006

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • DelRicht Research

    Prosper, Texas, 75078

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • NorCal Clinical Research

    Rocklin, California, 95765

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Georgia Skin & Cancer Clinic

    Savannah, Georgia, 31419

  • University of Washington Medical Center

    Seattle, Washington, 98164

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202

Other trials in United States

Germany8 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Katholische Klinikum Bochum gGmbH

    Bochum, 44791

  • Klinikum Darmstadt

    Darmstadt, 64283

  • University Hospital Dresden

    Dresden, 01307

  • Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

    Hamburg, 20251

  • University Clinic Dermatology Heidelberg

    Heidelberg, 69120

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, 80337

  • University Hospital Muenster - Münster

    Münster, 48149

Other trials in Germany

Poland7 sites

  • RENEW Clinic

    Bialystok, 15-797

  • Provita Centrum Medyczne Sp. z o.o. Katowice

    Katowice, 40-611

  • Provita Sp. z o. o.

    Katowice, 40-611

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

    Malbork, 82200

  • SOLUMED

    Poznan, 60-425

  • Laser Clinic S.C.

    Szczecin, 70-332

  • Manufaktura Zdrowia i Urody

    Warsaw, 02-922

Other trials in Poland

Canada5 sites

  • Ryan Clinical Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • North York Research Inc

    North York, Ontario, M2J 5B2

  • Centre de recherche Saint-Louis

    Québec, Quebec, G1W 4R4

  • York Dermatology Clinic & Research Centre

    Richmond Hill, Ontario, L4B 1L1

  • Saskatoon Dermatology Centre

    Saskatoon, Saskatchewan, S7T 0G3

Other trials in Canada

Spain4 sites

  • Edificio IMIBIC, Reina Sofia University Hospital

    Córdoba, 14004

  • Gregorio Marañón General University Hospital

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Hungary3 sites

  • Semmelweis University

    Budapest, 1085

  • University of Debrecen

    Debrecen, 4032

  • University of Szeged

    Szeged, 6720

Other trials in Hungary

About this study

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

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)

Being tested
Tibulizumab Dose A, Tibulizumab Dose B, Placebo
Keywords
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
Medical subject headings
Hidradenitis Suppurativa, Skin Diseases, Dermatitis, Sweat Gland Diseases, Skin Diseases, Bacterial, Hidradenitis, Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tibulizumab Dose ABiological

    Anti BAFF/IL-17 antibody. ZB-106

  • Tibulizumab Dose BBiological

    Anti BAFF/IL-17 antibody. ZB-106

  • PlaceboOther

    ZB-106 Placebo

Study groups in NCT06993610
Study groupRoleWhat they receive
Tibulizumab Dose AExperimentalSubcutaneous injection
Receives: Biological: Tibulizumab Dose A
Tibulizumab Dose BExperimentalSubcutaneous injection
Receives: Biological: Tibulizumab Dose B
PlaceboPlacebo comparatorSubcutaneous injection
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Week 16

Secondary outcomes (6)

  1. [Period 1] Achieving HiSCR50 at 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

    Measured: Week 16

  2. [Period 1] Achieving HiSCR75 at 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

    Measured: Week 16

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

    Measured: Week 16

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

    Measured: Week 16

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

    Measured: Week 16

  6. [Period 1] Safety and tolerability of tibulizumab

    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.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start16 May 2025
  3. Primary completion18 Sep 2026
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06993610
Sponsor's protocol ID
ZB-106-HS-202
Other IDs
2024-519736-17-00
Acronym
TibuSHIELD
Status last verified
Oct 2026
First submitted
19 May 2025
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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