Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZura Bio Inc
About this trial
The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)
Eligibility criteria
Qualifiers
Male or female, 18 to 75 years of age
Body mass index between 18.0 and 38.0 kg/m²
Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria
Has diffuse cutaneous SSc, defined as mRSS >0 over at least one skin area proximal to the elbows and/or knees, in addition to acral fibrosis
Disqualifiers
Left ventricular failure
Pulmonary arterial hypertension
Renal crisis within previous 6 months
Gastrointestinal dysmotility within previous 3 months
Trial design
Treatments tested in this trial
- Tibulizumab
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov