A study to find if tibulizumab works and how safe it is in participants with systemic sclerosis

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

22 Dec 2025 → ongoing

Decision date (initial)

2025-11-28

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Zura Bio Inc.

External identifiers

EU CT number

2024-519335-42-01

ClinicalTrials.gov

NCT06843239

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

Period 1: To assess the effect of tibulizumab on skin thickness in patients with SSc

Period 2: To assess the safety and tolerability of tibulizumab in patients with SSc

Secondary objectives 5

1. Period 1 and 2: To assess the effect of tibulizumab on lung involvement in patients with SSc-interstitial lung disease (ILD)
2. Period 1: To assess the effect of tibulizumab on lung function in patients with SSc-ILD
3. Period 1: To assess the effect of tibulizumab on systemic sclerosis-related function and QoL, in patients with SSc
4. Period 1: To assess the safety and tolerability of tibulizumab when administered to patients with SSc.
5. Period 2: To assess the effect of tibulizumab on skin thickness in patients with SSc

Conditions and MedDRA coding

Systemic Sclerosis

Study design 2 periods

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 10

1. 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.
2. 2. Is male or female 18 to 75 years of age (both inclusive) at the time of signing informed consent.
3. 3. Has a BMI between 18.0 and 38.0 kg/m2, inclusive, at the time of signing informed consent.
4. 4. Fulfills classification of SSc according to ACR and EULAR 2013 criteria.
5. 5. Has diffuse cutaneous SSc
6. 6. Has had SSc (first non-RP symptom or sign attributed to SSc) for ≤7 years at time of informed consent.
7. 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)
8. 8. Has FVC >50% predicted at screening and Day 1
9. 9. Has DLCO ≥40% predicted (corrected for Hb) at screening.
10. 10. Has agreed to adhere to the contraception requirements defined in the clinical protocol.

Exclusion criteria 20

1. All exclusion criteria can be found in the protocol (section 5.2). Key Exclusion Criteria: Any 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
2. 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
3. Digital ischemia with gangrene, amputation, or unscheduled hospitalization requiring treatment at screening, Day 1 or within previous 3 months
4. Any current rheumatic disease other than SSc that could interfere with assessment of SSc.
5. ACA-positive (if also positive with either RNA polymerase III or anti-topoisomerase I then allowed in the study)
6. Lung disease requiring continuous oxygen therapy
7. Evidence or suspicion of active or latent tuberculosis
8. Active Crohn’s Disease or ulcerative colitis
9. History of opportunistic or serious infection within the past 3 months, or infection requiring systemic antibiotics with 2 weeks of first dose
10. Current active liver disease
11. History of anaphylaxis to any biologic
12. History of known immunodeficiency disorder
13. 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
14. 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
15. 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
16. Previous exposure to Tibulizumab
17. Previous treatment with chlorambucil, stem cell or bone marrow transplantation, cell therapy, stem cell transplant, or total lymphoid irradiation
18. History of allergy or severe reaction to any component of the formulation
19. Inability to lie flat, or presence of metallic artifact or pacemaker
20. Female participants who are pregnant, likely to become pregnant, breastfeeding, or lactating

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Period 1: Change from baseline at Week 24 in modified Rodnan Skin Score (mRSS)
2. Period 2: Incidence of all treatment-emergent adverse events; change in baseline in vital signs, electrocardiogram (ECG) parameters, and clinical laboratory results

Secondary endpoints 5

1. 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
2. Period 1: Change from baseline at Week 24 in forced vital capacity (mL)
3. Period 1: Change from baseline at Week 24 in Health Assessment Questionnaire Disability Index
4. Period 1: Incidence of all treatment-emergent adverse events; Change from baseline in vital signs, electrocardiogram parameters, and clinical laboratory results
5. Period 2: Change from baseline at Week 52 in modified Rodnan Skin Score (mRSS)

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 14

Locations

4 EU/EEA countries · 23 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 39 files

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

Application history

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