Tibulizumab for Scleroderma

Recruiting at 26 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zura Bio Inc

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tibulizumab, a new treatment for systemic sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. The researchers aim to evaluate tibulizumab's effectiveness over a 24-week period compared to a placebo (a non-active treatment), followed by an open-label period where all participants receive tibulizumab for further evaluation. The trial seeks individuals who have had systemic sclerosis for 7 years or less and exhibit symptoms like skin thickening near the elbows or knees. Participants will receive the treatment through a subcutaneous injection (an injection under the skin). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that tibulizumab is likely to be safe for humans?

Research is examining how tibulizumab affects systemic sclerosis, a condition that thickens the skin and lungs. The studies focus on the safety and tolerability of tibulizumab, assessing whether people can take the drug without serious side effects. As this trial is in an early phase, tibulizumab has shown some safety in humans but requires further testing. In later phases, more safety information would be available. The research continues to ensure its safety for wider use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for scleroderma?

Unlike the standard treatments for scleroderma, which often include immunosuppressants and medications like methotrexate and mycophenolate mofetil, Tibulizumab is unique because it offers a new approach by targeting specific pathways involved in the disease. Researchers are excited about Tibulizumab because it is administered via a subcutaneous injection, making it potentially more convenient compared to some existing treatment options that require oral or intravenous administration. Additionally, Tibulizumab may have a novel mechanism of action that could provide benefits for patients who do not respond well to current therapies, potentially offering a more effective way to manage the symptoms of scleroderma.

What evidence suggests that tibulizumab might be an effective treatment for scleroderma?

Research has shown that tibulizumab, which participants in this trial may receive, might help treat systemic sclerosis, a disease that causes the skin and other organs to harden. This treatment targets proteins that cause inflammation, such as IL-17A and BAFF, potentially reducing disease symptoms. Early findings suggest that tibulizumab is generally safe and causes few harmful effects. While the initial results are promising, further studies are needed to confirm its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

Zura Bio Inc

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tibulizumab

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Tocilizumab, administered every two weeks, showed a decrease in the modified Rodnan's score after 4 weeks in a 44-year-old female patient with systemic scleroderma, indicating its potential effectiveness in treating skin fibrosis.

The treatment was well-tolerated with no side effects reported after 6 months, suggesting that tocilizumab may be a safe option for maintaining lung function and improving symptoms in scleroderma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tocilizumab in systemic sclerosis treatment: a case report. Kudsi, M., Khalayli, N., Tarcha, R., et al.[2023]

Cyclophosphamide is the primary treatment for progressive skin involvement and active interstitial lung disease in scleroderma, while mycophenolate mofetil shows promise as an alternative.

Newer therapies targeting T-cells (like sirolimus and alefacept) and B-cells (like rituximab) have shown encouraging results in small studies, but the safety and efficacy of antifibrotic treatments like imatinib still need further confirmation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of systemic sclerosis. Manno, R., Boin, F.[2022]

In a pilot study of 13 patients with recent-onset diffuse scleroderma, treatment with anti-thymocyte globulin (ATG) followed by mycophenolate mofetil (MMF) resulted in a significant decrease in skin score from 28 to 17 over 12 months, indicating improved skin condition.

While MMF was well tolerated, some patients experienced adverse effects, including serum sickness in five patients, which was manageable with corticosteroids, suggesting that while the treatment is generally safe, monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of anti-thymocyte globulin plus mycophenolate mofetil in recent-onset diffuse scleroderma. Stratton, RJ., Wilson, H., Black, CM.[2019]

Citations

1.

investors.zurabio.com

investors.zurabio.com/news-releases/news-release-details/zura-bio-launches-global-phase-2-tibusure-study-evaluate

Zura Bio Launches Global Phase 2 TibuSURE Study to ...

TibuSURE is a global Phase 2 double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of tibulizumab in approximately 80 ...

2.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/partner/nationalsclerodermafoundation/trial/578719

Tibulizumab Systemic Sclerosis Understanding and ...

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks.

3.

scleroderma.org.au

scleroderma.org.au/news/phase-2-trial-tests-tibulizumab-in-adults-with-diffuse-ssc

Phase 2 trial tests tibulizumab in adults with diffuse SSc

The treatment demonstrated an acceptable safety profile, with no new findings compared with antibodies targeting either IL-17A or BAFF. The ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12215137/

New horizons in systemic sclerosis treatment: advances and ...

Rituximab (RTX) has shown consistent efficacy. The DESIRES trial reported stabilisation of FVC (+0.09% vs −2.87%; p=0.044), while the Sircar ...

5.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/578719

Tibulizumab Systemic Sclerosis Understanding and ...

The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks.

6.

tibusure.patientwing.com

tibusure.patientwing.com/

TibuSURE | PatientWing: SSc Clinical Study

The purpose of this study is to evaluate the effect of tibulizumab on skin thickening, lung thickening, and function. You may know scleroderma as systemic ...

7.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/zura-bio-submits-scleroderma-drug-protocol-for-fda-phase-2-study/

Zura Bio Submits Scleroderma Drug Protocol for FDA ...

It will assess the safety, tolerability, and efficacy of tibulizumab in approximately 80 adults with early diffuse cutaneous SSc (dcSSc).

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6748573/

Development of tibulizumab, a tetravalent bispecific antibody ...

Development of tibulizumab, a tetravalent bispecific antibody targeting BAFF and IL-17A for the treatment of autoimmune disease