Tibulizumab for Scleroderma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Zura Bio Inc

Disqualifiers: Left ventricular failure, Pulmonary hypertension, Renal crisis, others

Prior Safety Data

Trial Summary

What is the purpose of 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)

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

How is the drug Tibulizumab different from other drugs for scleroderma?

Tibulizumab may be unique in its approach to treating scleroderma by potentially targeting specific immune pathways, similar to how tocilizumab, an anti-interleukin-6 receptor antibody, is used to manage the condition. This could offer a new mechanism of action compared to traditional treatments like cyclophosphamide, which broadly suppress the immune system. ^{1 2 3 4 5}

Research Team

Study Director

Principal Investigator

Zura Bio Inc

Eligibility Criteria

This trial is for adults with systemic sclerosis, a condition where skin and connective tissues harden. Participants must meet specific health criteria to join, but the exact inclusion and exclusion details aren't provided here.

Inclusion Criteria

Fulfills classification criteria for SSc according to ACR/EULAR 2013 criteria

FVC >50% predicted

Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)

Exclusion Criteria

Current rheumatic disease other than SSc that could interfere with assessment of SSc

I have active Crohn's Disease or ulcerative colitis.

I have had serious heart, lung, kidney, stomach, or circulation problems in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tibulizumab or placebo for 24 weeks in a double-blind, placebo-controlled manner

24 weeks

Open-label extension

All participants receive tibulizumab and are evaluated for safety and efficacy over an additional 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after the open-label extension

4 weeks

Treatment Details

Interventions

• Tibulizumab (Monoclonal Antibodies)

Trial Overview The TibuSURE study tests tibulizumab against a placebo in a two-part process: first, participants are randomly assigned to receive either the drug or placebo for 24 weeks; then all get tibulizumab for another 28 weeks.

Participant Groups

Group I: Tibulizumab Experimental Treatment 1 Intervention

Subcutaneous injection

Group II: Placebo Placebo Group 2 Interventions

Subcutaneous injection

Who Is Running the Clinical Trial?

Zura Bio Inc

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

In a phase II study involving patients with systemic sclerosis (SSc), tocilizumab treatment for 48 weeks led to a significant improvement in skin scores and stabilization of lung function, as measured by the modified Rodnan Skin Score (mRSS) and forced vital capacity (%pFVC).

While tocilizumab was associated with an increased rate of serious infections compared to placebo, no new safety concerns were identified, suggesting that while the drug is effective, monitoring for infections is important during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Khanna, D., Denton, CP., Lin, CJF., et al.[2019]

In a phase 3 trial involving 210 participants, tocilizumab did not significantly improve skin fibrosis compared to placebo, as indicated by the modified Rodnan skin score (mRSS) change after 48 weeks.

However, tocilizumab showed a positive effect on lung function, with a significant improvement in forced vital capacity (FVC%) compared to placebo, suggesting it may help preserve lung function in early systemic sclerosis-associated interstitial lung disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. Khanna, D., Lin, CJF., Furst, DE., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). [2019]

2. England pubmed.ncbi.nlm.nih.gov

Pilot study of anti-thymocyte globulin plus mycophenolate mofetil in recent-onset diffuse scleroderma. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Tocilizumab in systemic sclerosis treatment: a case report. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Immunotherapy of systemic sclerosis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Tocilizumab in systemic sclerosis: a randomised, double-blind, placebo-controlled, phase 3 trial. [2021]