A study to determine the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zura Bio Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

3 Oct 2025 → ongoing

Decision date (initial)

2025-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Zura Bio, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Pharmacogenetic, Pharmacokinetic, Safety, Pharmacodynamic, Efficacy

To assess the effect of tibulizumab on HS lesions in patients with HS

Secondary objectives 2

1. To assess the effect of tibulizumab on HS‑related quality of life in patients with HS
2. To assess the safety and tolerability of tibulizumab when administered to patients with HS

Conditions and MedDRA coding

Hidradenitis Suppurativa

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Male or female participant aged 18 to 70 years, inclusive, at the time of consent
2. For female participant of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from ≥4 weeks prior to Day 1 until ≥12 weeks after the last study treatment administration and have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day 1.
3. For male participant involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use a highly effective contraceptive method from Day 1 until ≥12 weeks after the last study product administration.
4. Female participant: must agree to not donate oocytes or undergo in vitro fertilization from the first study treatment administration until ≥12 weeks following the last study treatment administration.
5. Male participant: must agree to not donate sperm from the first study treatment administration until ≥12 weeks following the last study treatment administration.
6. Participant has provided written informed consent prior to any trial-related activities.
7. Participant must be willing and able to comply with all study procedures and visits, and must be available for the duration of the study.
8. Participant has ≥6-month history of HS based on the investigator’s judgement (through participant interview and/or review of medical charts) at screening
9. Participant had an inadequate response to an appropriate course of oral antibiotics for the treatment of HS OR demonstrated intolerance to, OR has a contraindication to, OR exhibited recurrence after discontinuation with oral antibiotics for the treatment of their HS based on investigator’s judgement through participant interview and/or review of medical history.
10. Participant has a total AN count of ≥5 at screening and Day 1.
11. Participant has HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III at screening and Day 1.

Exclusion criteria 19

1. Female who is breastfeeding, pregnant, or planning to become pregnant during the study.
2. Positive result for hepatitis B virus hepatitis C virus, or human immunodeficiency virus (HIV). Note: History of hepatitis B infection will be allowed if hepatitis B DNA is undetectable and remains negative.
3. History of anaphylaxis to any biologic therapy or vaccine.
4. History of cancer or lymphoproliferative disease within 5 years. Note: Successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is allowed.
5. History of clinically significant drug or alcohol abuse in the last 6 months.
6. Major surgery within 4 weeks or has a major surgery planned during the study.
7. Clinically significant medical condition that would put the participant at undue risk, interfere with study results, or completion of study.
8. Known or suspected allergy to ZB-106 (tibulizumab) or any component of the investigational product.
9. Unable to tolerate SC drug administration.
10. Institutionalized because of legal or regulatory order.
11. In the opinion of the investigator, the participant should not participate in the trial.
12. Presence of another inflammatory condition or skin condition that may interfere with study assessments. Note: Diagnosis of Crohn’s disease or ulcerative colitis is allowed if no active symptomatic disease.
13. Known to have immune deficiency or is immunocompromised.
14. Evidence or suspicion of active or latent tuberculosis.
15. History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, had a serious infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks.
16. Active systemic candidiasis. Note: Urogenital candidiasis is allowed.
17. Lifetime history of suicide attempt, had suicidal ideation in the past 6 months, or who, in the investigator's opinion, poses a significant suicide risk.
18. Has any of the following laboratory values (screening visit): a. Hemoglobin <8.5 g/100 mL b. Absolute neutrophil count <1500/mm3 c. Platelet count <100 000/mm3 d. Alanine aminotransferase or aspartate aminotransferase values ≥2 times the upper limit of normal e. Estimated glomerular filtration rate <45 mL/min/1.73 m2
19. Used any of the following: a. Prior use of anti-IL-17 or anti-BAFF therapies. b. B cell-depleting biologics within 12 months. c. Glucagon-like peptide-1 receptor agonists or any other therapy that causes significant weight loss, within 6 months. Note: Use of therapies that cause significant weight loss will be allowed if participant has been on a stable dose for ≥6 months and continues the same dose. d. Marketed (eg, adalimumab) or investigational biological agents within 12 weeks or 5 half‑lives (whichever is longer). e. Receipt of Ig or blood products within 4 weeks. f. Receipt of a live or live-attenuated vaccine within 4 weeks or plans to receive a live or live-attenuated vaccine during the study. g. Systemic non-biologic therapies that could affect HS within 4 weeks. Note: Intranasal corticosteroids, inhaled corticosteroids, eye and ear drops containing corticosteroids, are allowed. h. Systemic antibiotics for the treatment of HS within 4 weeks. Note: Tetracyclines are allowed if stable dose for ≥4 weeks, and current dose maintained during the study. i. Surgical, laser, or intense pulse light intervention in anatomic areas of HS lesions within 4 weeks. j. Nonbiological investigational product or medical device within 4 weeks. k. Analgesics for pain (HS or non-HS related) or opioid analgesics (except tramadol) within 2 weeks. Note: Use of oral, non-opioid analgesics for the management of non-HS medical conditions will be allowed if stable dose for ≥2 weeks and maintain dose during the study. l. Prescription topical medication for the treatment of HS within 2 weeks. Note: Stable use of antiseptics allowed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16

Secondary endpoints 3

1. Achieving HiSCR50 at Week 16; Achieving HiSCR75 at Week 16
2. Absolute change from baseline in Dermatology Life Quality Index (DLQI) score at Week 16; Absolute change from baseline in Patient's Global Assessment of Hidradenitis Suppurativa (HS-PtGA) score at Week 16; Absolute change from baseline in skin pain numerical rating scale (NRS) at Week 16
3. Incidence and severity of treatment emergent adverse events (TEAEs); Absolute change from baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zura Bio Inc.

Sponsor organisation

Zura Bio Inc.

Address

1489 West Warm Springs Road

City

Henderson

Postcode

89014-7635

Country

United States

Scientific contact point

Organisation

Zura Bio Inc.

Contact name

Shelly Shirkey

Public contact point

Organisation

Zura Bio Inc.

Contact name

Corporate Communications

Third parties 5

Locations

4 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications