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A study to find if tibulizumab works and how safe it is in participants with systemic sclerosis
EU CTIS ID: 2024-519335-42-01
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 10. Has agreed to adhere to the contraception requirements defined in the clinical protocol.
- 2. Is male or female 18 to 75 years of age (both inclusive) at the time of signing informed consent.
- 3. Has a BMI between 18.0 and 38.0 kg/m2, inclusive, at the time of signing informed consent.
- 4. Fulfills classification of SSc according to ACR and EULAR 2013 criteria.
- 5. Has diffuse cutaneous SSc
You likely can't join if
- 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
- Current active liver disease
- History of anaphylaxis to any biologic
- History of known immunodeficiency disorder
- 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
- 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
See the full eligibility criteria
Who can join
- 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.
- 10. Has agreed to adhere to the contraception requirements defined in the clinical protocol.
- 2. Is male or female 18 to 75 years of age (both inclusive) at the time of signing informed consent.
- 3. Has a BMI between 18.0 and 38.0 kg/m2, inclusive, at the time of signing informed consent.
- 4. Fulfills classification of SSc according to ACR and EULAR 2013 criteria.
- 5. Has diffuse cutaneous SSc
- 6. Has had SSc (first non-RP symptom or sign attributed to SSc) for ≤7 years at time of informed consent.
- 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. Has FVC >50% predicted at screening and Day 1
- 9. Has DLCO ≥40% predicted (corrected for Hb) at screening.
What rules you out
- 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
- Current active liver disease
- History of anaphylaxis to any biologic
- History of known immunodeficiency disorder
- 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
- 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
- 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
- Previous exposure to Tibulizumab
- Previous treatment with chlorambucil, stem cell or bone marrow transplantation, cell therapy, stem cell transplant, or total lymphoid irradiation
- History of allergy or severe reaction to any component of the formulation
- Inability to lie flat, or presence of metallic artifact or pacemaker
- 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
- Female participants who are pregnant, likely to become pregnant, breastfeeding, or lactating
- Digital ischemia with gangrene, amputation, or unscheduled hospitalization requiring treatment at screening, Day 1 or within previous 3 months
- Any current rheumatic disease other than SSc that could interfere with assessment of SSc.
- ACA-positive (if also positive with either RNA polymerase III or anti-topoisomerase I then allowed in the study)
- Lung disease requiring continuous oxygen therapy
- Evidence or suspicion of active or latent tuberculosis
- Active Crohn’s Disease or ulcerative colitis
- History of opportunistic or serious infection within the past 3 months, or infection requiring systemic antibiotics with 2 weeks of first dose
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United States
- Mexico
- United Kingdom
- Argentina
- Canada
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United States; Mexico; United Kingdom; Argentina; Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.