Tibulizumab

Table of contents

• What is tibulizumab?
• How does tibulizumab work?
• Which conditions is tibulizumab studied for?
• How is tibulizumab given?
• What do the clinical trials show?
• What side effects are known?

What is tibulizumab?

Tibulizumab is a protein-based substance classified as an investigational medicine, meaning it has no marketing authorisation in the product records reviewed here.^[1] It is being developed by Zura Bio Inc. and appears in the EU Clinical Trials Information System (CTIS) registry under the name tibulizumab.^[1] The substance falls under the therapeutic area of immune system diseases.^[1] Its role in the trials listed is as the test substance in one trial record.^[1]

How does tibulizumab work?

The registry records do not state the molecular target or mechanism of action of tibulizumab. It is described as a protein-based substance, which means it is a biological medicine rather than a chemically synthesised small molecule.^[1] Biological medicines are typically designed to interact with specific parts of the immune system. The precise way tibulizumab acts is not described in the available registry data.

Which conditions is tibulizumab studied for?

Two conditions are being investigated in the authorised trials:

• Hidradenitis suppurativa — a chronic inflammatory skin condition causing painful lumps, abscesses and tunnels under the skin, often in areas such as the armpits and groin.^[1]
• Systemic sclerosis — a rare autoimmune disease that causes thickening and hardening of the skin and can affect internal organs.^[2]

How is tibulizumab given?

Tibulizumab is prepared as a solution for injection and is given by subcutaneous injection, meaning it is injected under the skin.^[1] In the trial records, the dose is listed as 00 mg, which indicates the dose was not reported in the register. Both trials include a placebo arm for comparison.^[1][2]

What do the clinical trials show?

Two Phase 2 trials of tibulizumab are authorised. One trial, with EU CT number 2024-519736-17-00, is studying tibulizumab in adults with hidradenitis suppurativa and plans to enrol 225 participants.^[1] The primary outcome is the percentage change from baseline in abscess and inflammatory nodule (AN) count at Week 16.^[1] The second trial, NCT06843239, is studying tibulizumab in participants with systemic sclerosis and plans to enrol 80 participants.^[2] Its primary outcomes include the change from baseline at Week 24 in modified Rodnan Skin Score (mRSS), which measures skin thickness, and the incidence of treatment-emergent adverse events.^[2] Both trials are interventional and compare tibulizumab with placebo.^[1][2]

What side effects are known?

The registry records do not provide information on side effects of tibulizumab. The systemic sclerosis trial includes the incidence of all treatment-emergent adverse events as an outcome in its second period, meaning safety data will be collected during the study.^[2]