TIBULIZUMAB for Systemic sclerosis | Systemic sclerosis-associated interstitial lung disease

Inclusion criteria

• {"criterion_text":"- All inclusion criteria can be found in the protocol (section 5.1). 1. Understands the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.\n- 10. Has agreed to adhere to the contraception requirements defined in the clinical protocol.\n- 2. Is male or female 18 to 75 years of age (both inclusive) at the time of signing informed consent.\n- 3. Has a BMI between 18.0 and 38.0 kg/m2, inclusive, at the time of signing informed consent.\n- 4. Fulfills classification of SSc according to ACR and EULAR 2013 criteria.\n- 5. Has diffuse cutaneous SSc\n- 6. Has had SSc (first non-RP symptom or sign attributed to SSc) for ≤7 years at time of informed consent.\n- 7. mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase 3 positive (see protocol)\n- 8. Has FVC >50% predicted at screening and Day 1\n- 9. Has DLCO ≥40% predicted (corrected for Hb) at screening."}

Exclusion criteria

• {"criterion_text":"- All exclusion criteria can be found in the protocol (section 5.2). Key Exclusion Criteria: \tAny of the following present: Left ventricular failure (ejection fraction <45%), Pulmonary arterial hypertension requiring either oral or parenteral treatments or requiring continuous oxygen therapy, Renal crisis within previous 6 months, Gastrointestinal dysmotility requiring enteral or parenteral nutrition at screening, Day 1 or in the 3 months prior to screening\n- Current active liver disease\n- History of anaphylaxis to any biologic\n- History of known immunodeficiency disorder\n- Current (or history of) malignancy, except for: Basal cell carcinoma, localized squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other malignancies are eligible, provided that the participant is in remission\n- Has any clinically significant abnormal findings during the screening period which, in the opinion of the investigator, may put the participant at risk, or may influence the results of the study, or the inability to complete the entire duration of the study\n- Any disorder or major physical impairment that is not stable in the opinion of the investigator and could affect the safety of the participant, influence the findings, or impede the participant's ability to complete the study\n- Previous exposure to Tibulizumab\n- Previous treatment with chlorambucil, stem cell or bone marrow transplantation, cell therapy, stem cell transplant, or total lymphoid irradiation\n- History of allergy or severe reaction to any component of the formulation\n- Inability to lie flat, or presence of metallic artifact or pacemaker\n- Any of the following laboratory values (at the screening visit): Hemoglobin value <8.5 g/100 mL, Neutrophil value <1500/mm3, Platelet count <100 000/mm3, Estimated glomerular filtration rate <45 mL/min/1.73 m2\n- Female participants who are pregnant, likely to become pregnant, breastfeeding, or lactating\n- Digital ischemia with gangrene, amputation, or unscheduled hospitalization requiring treatment at screening, Day 1 or within previous 3 months\n- Any current rheumatic disease other than SSc that could interfere with assessment of SSc.\n- ACA-positive (if also positive with either RNA polymerase III or anti-topoisomerase I then allowed in the study)\n- Lung disease requiring continuous oxygen therapy\n- Evidence or suspicion of active or latent tuberculosis\n- Active Crohn’s Disease or ulcerative colitis\n- History of opportunistic or serious infection within the past 3 months, or infection requiring systemic antibiotics with 2 weeks of first dose"}

Primary endpoints

• {"endpoint_text":"- Period 1: Change from baseline at Week 24 in modified Rodnan Skin Score (mRSS)","definition_or_measurement_approach":"Change from baseline to Week 24 in modified Rodnan Skin Score (mRSS) measured by mRSS assessments at baseline and Week 24."}
• {"endpoint_text":"- Period 2: Incidence of all treatment-emergent adverse events; change in baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent adverse events over Period 2; and change-from-baseline comparisons for vital signs, ECG parameters and clinical laboratory results (safety assessments)."}

Secondary endpoints

• {"endpoint_text":"- Period 1 and 2: Change from baseline at Week 24 in quantitative interstitial lung disease obtained with high-resolution quantitative tomography in the whole lung","definition_or_measurement_approach":"Change from baseline to Week 24 in quantitative interstitial lung disease (QILD) measured by high-resolution quantitative tomography (HRCT) of the whole lung."}
• {"endpoint_text":"- Period 1: Change from baseline at Week 24 in forced vital capacity (mL)","definition_or_measurement_approach":"Change from baseline to Week 24 in forced vital capacity (FVC) in mL measured by spirometry."}
• {"endpoint_text":"- Period 1: Change from baseline at Week 24 in Health Assessment Questionnaire Disability Index","definition_or_measurement_approach":"Change from baseline to Week 24 in HAQ-DI score assessed using the Health Assessment Questionnaire Disability Index instrument."}
• {"endpoint_text":"- Period 1: Incidence of all treatment-emergent adverse events; Change from baseline in vital signs, electrocardiogram parameters, and clinical laboratory results","definition_or_measurement_approach":"Incidence of TEAEs during Period 1 and change-from-baseline assessments for vital signs, ECG parameters and clinical laboratory tests."}
• {"endpoint_text":"- Period 2: Change from baseline at Week 52 in modified Rodnan Skin Score (mRSS)","definition_or_measurement_approach":"Change from baseline to Week 52 in mRSS measured by mRSS assessments at baseline and Week 52."}

Methods

• Site-based recruitment via participating hospitals/clinics listed per country (Spain, Poland, Hungary, Romania) — site referral and local site materials.
• Digital recruitment using PatientWing / PatientWing-related materials and privacy policy (documents K2, PatientWing materials present in ES and PL packages) — online/digital channel to reach potential participants.
• Country-language recruitment materials provided (documents K1/K2 and ICFs in ES/PL/HU/RO/ENG) enabling local-language outreach.

Spain

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

73

Number Of Sites

3

Number Of Participants

6

Poland

Earliest CTIS Part Ii Submission Date

14-11-2025

Latest Decision Or Authorization Date

30-11-2025

Processing Time Days

16

Number Of Sites

12

Number Of Participants

20

Hungary

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

17-12-2025

Processing Time Days

93

Number Of Sites

2

Number Of Participants

4

Romania

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

19-12-2025

Processing Time Days

95

Number Of Sites

7

Number Of Participants

7

Primary sponsor

Full Name

Zura Bio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

sponsorDuties codes: [1,11,12,13,2,5,6,8]

Name

PPD International Holdings LLC

Responsibilities

sponsorDuties codes: [4]

Name

Pharmaceutical Product Development LLC

Responsibilities

sponsorDuties codes: [4]

Third parties

• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: [1,11,12,13,2,5,6,8]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Voiant LLC","duties_or_roles":"HRCT Central Reader (sponsorDuties code: 15; value: 'HRCT Central Reader')","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Nuvoair Inc.","duties_or_roles":"Spirometry (FVC Assessment and Central Reading) (sponsorDuties code: 15; value provided)","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"VitalTrax LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [13,8]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement (sponsorDuties code: 15; value: 'Patient reimbursement')","organisation_type":"Non-Pharmaceutical company"}