TIBULIZUMAB for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Male or female participant aged 18 to 70 years, inclusive, at the time of consent\n- Participant has a total AN count of ≥5 at screening and Day 1.\n- 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.\n- 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.\n- 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.\n- 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.\n- Male participant: must agree to not donate sperm from the first study treatment administration until ≥12 weeks following the last study treatment administration.\n- Participant has provided written informed consent prior to any trial-related activities.\n- Participant must be willing and able to comply with all study procedures and visits, and must be available for the duration of the study.\n- Participant has ≥6-month history of HS based on the investigator’s judgement (through participant interview and/or review of medical charts) at screening\n- 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."}

Exclusion criteria

• {"criterion_text":"- Female who is breastfeeding, pregnant, or planning to become pregnant during the study.\n- Institutionalized because of legal or regulatory order.\n- In the opinion of the investigator, the participant should not participate in the trial.\n- 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.\n- Known to have immune deficiency or is immunocompromised.\n- Evidence or suspicion of active or latent tuberculosis.\n- 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.\n- Active systemic candidiasis. Note: Urogenital candidiasis is allowed.\n- 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.\n- 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\n- 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.\n- 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.\n- History of anaphylaxis to any biologic therapy or vaccine.\n- 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.\n- History of clinically significant drug or alcohol abuse in the last 6 months.\n- Major surgery within 4 weeks or has a major surgery planned during the study.\n- Clinically significant medical condition that would put the participant at undue risk, interfere with study results, or completion of study.\n- Known or suspected allergy to ZB-106 (tibulizumab) or any component of the investigational product.\n- Unable to tolerate SC drug administration."}

Primary endpoints

• {"endpoint_text":"- Percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16","definition_or_measurement_approach":"Percent change from baseline AN count measured at Week 16 (abscess and inflammatory nodule count compared to baseline)."}

Secondary endpoints

• {"endpoint_text":"- Achieving HiSCR50 at Week 16; Achieving HiSCR75 at Week 16","definition_or_measurement_approach":"Proportion of participants achieving HiSCR50 and HiSCR75 at Week 16 (HiSCR response criteria measured at Week 16)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Absolute change from baseline in DLQI, HS-PtGA and skin pain NRS scores measured at Week 16."}
• {"endpoint_text":"- Incidence and severity of treatment emergent adverse events (TEAEs); Absolute change from baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results","definition_or_measurement_approach":"Safety endpoints: incidence and severity of TEAEs; absolute changes from baseline in vital signs, ECG parameters and clinical laboratory values (as recorded during study visits)."}

Methods

• Central and country-specific advertisements (documents titled 'K2_Advertisement Document' / 'K2_Central Advertisement Document')
• Digital landing page pre-screener (documents titled 'K2_Clinago Landing Page_Pre-screener Screenshot')
• Contact script for outreach (documents titled 'K2_Contact Script')
• Doctor-to-patient letters (documents titled 'K2_Doctor to Patient Letter')
• Flyers and patient brochures (documents titled 'K2_Flyer' and 'K2_Patient Brochure')
• Recruitment statements (documents titled 'K1_Recruit Statement' for respective countries)

Hungary

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

278

Number Of Sites

3

Number Of Participants

9

Germany

Earliest CTIS Part Ii Submission Date

08-08-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

217

Number Of Sites

8

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

260

Number Of Sites

4

Number Of Participants

13

Poland

Earliest CTIS Part Ii Submission Date

11-08-2025

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

267

Number Of Sites

7

Number Of Participants

38

Primary sponsor

Full Name

Zura Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Innovaderm Research Inc.

Responsibilities

Central Monitoring; Risk Management; additional sponsor duties (codes 1,2,5,6,9,10,11,12,13)

Name

Fortrea Inc.

Responsibilities

Responsibility code 8 (role listed in sponsor duties)

Name

Fisher Clinical Services UK Limited

Responsibilities

Responsibility code 14 (role listed in sponsor duties)

Third parties

• {"country":"Canada","full_name":"Innovaderm Research Inc.","duties_or_roles":"Codes: 1,10,11,12,13,15 (Risk Management),15 (Central Monitoring),2,5,6,9","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Codes: 14","organisation_type":"Pharmaceutical company"}