Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tibulizumab · 1 trial · 2 indications
The mRSS assesses skin thickness at 17 different cutaneous sites across the body using a scale from 0 (normal skin) to 3 (severe thickening), with a total score ranging from 0 (no thickening) to 51 (severe thickening in all 17 areas)
Assessed by the incidence of all treatment-emergent adverse events (TEAEs), as well as changes from baseline in vital signs, electrocardiogram (ECG) parameters, and laboratory results
| Arm | Type | Description |
|---|---|---|
| Tibulizumab | EXPERIMENTAL | Subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Tibulizumab | BIOLOGICAL | Anti BAFF/IL-17 antibody |
| Placebo | OTHER | Placebo (inactive) |
Inclusion Criteria: * 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,...
Top 20 of 21 competitors
Tibulizumab is an investigational monoclonal antibody being developed for the treatment of Systemic Sclerosis (SSc), also known as scleroderma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with this autoimmune connective tissue disease.
Tibulizumab targets and inhibits two molecular targets: IL17A and TNFSF13B. IL17A is a pro-inflammatory cytokine involved in immune responses, while TNFSF13B, also known as B-cell activating factor, plays a role in B-cell survival and function. By inhibiting both targets, the drug aims to modulate inflammatory and autoimmune pathways relevant to Systemic Sclerosis.
Tibulizumab is being developed by Zura Bio Limited, a biopharmaceutical company traded on the stock exchange under the ticker symbol ZURA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Systemic Sclerosis.
Tibulizumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received approval from regulatory agencies such as the FDA. The ongoing Phase 2 trial is designed to assess its effects in patients with Systemic Sclerosis.
Tibulizumab is being evaluated in a Phase 2 clinical trial with the identifier NCT06843239, titled 'Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)'. This randomized, double-blind, placebo-controlled study enrolls approximately 80 participants across multiple countries, including the United States, Argentina, Chile, Hungary, Mexico, Poland, Romania, Serbia, Spain, and the United Kingdom.
Tibulizumab is a distinct investigational monoclonal antibody and no alternative names have been reported for this drug. It is being studied under the name Tibulizumab in clinical trials for Systemic Sclerosis, and no other brand or generic names have been associated with it in the available information.