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New antibody drug aims to halt Scleroderma's damage

NCT ID NCT06843239

Disease control Sponsor: Zura Bio Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a drug called tibulizumab in 80 adults with systemic sclerosis, a disease that causes skin thickening and can damage organs. Participants first receive either the drug or a placebo for 24 weeks, then everyone who continues gets the drug for another 28 weeks. The main goal is to see if the drug reduces skin thickness and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tibulizumab (an antibody that targets BAFF and IL-17)
What this could lead to
If successful, this could point toward a new treatment option to control skin thickening and lung damage in systemic sclerosis.
What could go wrong
This is an early Phase 2 trial with only 80 participants, so results may not apply to everyone. The drug may not improve symptoms or could cause side effects.
Why investors are watching

Zura Bio is a micro-cap company with few assets, so this Phase 2 trial of tibulizumab in systemic sclerosis is a major test of its pipeline. The study randomizes 80 adults to receive the drug or a placebo for 24 weeks, then gives all participants the drug for 28 more weeks. A clear result on efficacy or safety would give investors their first solid read on whether the drug works in this disease.

If it works: A positive result could establish tibulizumab as a credible treatment for systemic sclerosis, a disease with few approved options. That success could raise the company's profile and support further development of the drug.

If it fails: Phase 2 trials often fail to show a benefit over placebo, and this one has a small sample of 80 people. A negative or unclear result could set the program back and leave Zura Bio with little to show investors.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, in addition to acral fibrosis * Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years * mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive * FVC \>50% predicted * Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin) Exclusion Criteria: * Has any of the following complications: * Left ventricular failure * Pulmonary arterial hypertension * Renal crisis within previous 6 months * Gastrointestinal dysmotility within previous 3 months * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months * Current rheumatic disease other than SSc that could interfere with assessment of SSc * Lung disease requiring continuous oxygen therapy * Evidence or suspicion of active or latent tuberculosis * Active Crohn's Disease or ulcerative colitis

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Conditions

The condition(s) this trial relates to.

autoimmune disease diffuse scleroderma immune system disorder interstitial lung disease scleroderma skin disorder systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma Systemic sclerosis (SSC)

Contacts and locations

Locations

  • AES - AS - Clinica Mayo de Urgencias

    San Miguel de Tucumán, T4000IHE, Argentina

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

  • Aintree University Hospital

    Liverpool, L9 7AL, United Kingdom

  • CTR Estudios Clinicos

    Santiago, 7500000, Chile

  • Center for Clinical and Basic Research (CCBR)

    Bucharest, 030463, Romania

  • Centro Medico de Estudios Clinicos y Farmacovigilancia (CECYF)

    Buenos Aires, C1426ABP, Argentina

  • Centro de Estudios Clinicos Victoria Limitada (Cevic)

    Victoria, 4720000, Chile

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centro de Investigación y Prevención Cardiovascular-Arenales

    Buenos Aires, C1061, Argentina

  • Centro de Investigación y Tratamiento Reumatológico S.C

    Miguel Hidalgo, 11850, Mexico

  • Centro de especialidades médicas Vanguardia

    Temuco, 4810345, Chile

  • Centrum Medyczne Plejady

    Krakow, 30-363, Poland

  • Chapel Allerton Hospital

    Leeds, LS7 4SA, United Kingdom

  • ClinHouse Centrum Medyczne

    Zabrze, 41-807, Poland

  • Clinical Research Chile SpA

    Valdivia, 683, Chile

  • Colentina Clinical Hospital

    Bucharest, 020125, Romania

  • Consultora Integral de Salud Centro Médico Privado

    Córdoba, X5000KEH, Argentina

  • Consultorios Médicos Dr. Doreski

    Buenos Aires, C1426, Argentina

  • Corporacio Sanitaria Parc Tauli

    Barcelona, 08208, Spain

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, 4032, Hungary

  • Dermacross Clinica Dermatologica

    Vitacura, 7640881, Chile

  • Dr I Cantacuzino Clinical Hospital

    Bucharest, 030167, Romania

  • Enroll SpA

    Santiago, 8320000, Chile

  • Haywood Community Hospital

    Stoke-on-Trent, ST6 7AG, United Kingdom

  • Hiperdia Romania

    Bucharest, 41303, Romania

  • Hospital General de Agudos Dr. José María Ramos Mejia

    Buenos Aires, C1221AFC, Argentina

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • IRIS Research and Development LLC

    Plantation, Florida, 33324, United States

  • Institute of Rheumatology - PPDS

    Belgrade, 11000, Serbia

  • Instituto CER S.A.

    Quilmes, B1878DVB, Argentina

  • Instituto de Investigación Clínica TyT

    Buenos Aires, C1405BFN, Argentina

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, 02-665, Poland

  • M2M Med-ul.

    Chorzów, 41-500, Poland

  • MICS Centrum Medyczne Warszawa

    Warsaw, B1000-874, Poland

  • Malopolskie Badania Kliniczne Sp. z o.o.

    Krakow, 30-002, Poland

  • Malopolskie Centrum Kliniczne

    Krakow, 30-149, Poland

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mediadvance Clinical

    Chihuahua City, 31203, Mexico

  • Medical Care and Research S.A. de C.V.

    Mérida, 97070, Mexico

  • Military Medical Academy

    Belgrade, 11000, Serbia

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637, Poland

  • Ninewells Hospital

    Dundee, DD2 1SG, United Kingdom

  • Oaxaca Site Management Organization - Clinic - OSMO - PPDS

    Oaxaca City, 68000, Mexico

  • Organización Médica de Investigación

    Buenos Aires, C1015, Argentina

  • PanAmerican Clinical Research

    Guadalajara, 44670, Mexico

  • Policlinica SelfMed Clinique

    Timișoara, 300133, Romania

  • Pécsi Tudomanyegyetem - Vasvari Pal u.

    Pécs, 7622, Hungary

  • Rheumatology Associates

    Arlington, Texas, 76012, United States

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Royal National Hospital for Rheumatic Diseases

    Bath, BA1 3NG, United Kingdom

  • STAT Research S.A.

    Buenos Aires, Buenos Aires, C1023, Argentina

  • Santa Familia PTG Łódź

    Lodz, 90-003, Poland

  • Sf.Maria Clinical Hospital

    Bucharest, 11172, Romania

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100, Poland

  • Twoja Przychodnia PCM - ul.

    Poznan, 60-324, Poland

  • UCLA Department of Medicine

    Los Angeles, California, 90024, United States

  • UCSD Altman Clinical and Translational Research Institute Center for Clinical Research

    La Jolla, California, 92037, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

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