NCT06843239RECRUITINGIRB Ready

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)

Sponsored by Zura Bio Inc

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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)

Who Can Participate

Inclusion Criteria

Male or female, 18 to 75 years of age
Body mass index between 18.0 and 38.0 kg/mยฒ
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 โ‰ค7 years
mRSS โ‰ฅ15 and โ‰ค45 at screening. Additional requirements for participants โ‰ฅ2 years to โ‰ค7 years from SSc onset and RNA Polymerase III antibody positive
FVC \>50% predicted
Diffusing capacity of the lungs for carbon monoxide (DLCO) โ‰ฅ40% 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, o

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

80 participants

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Age Range

18 Years - 75 Years

โšง

Gender

ALL

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Sponsor

Zura Bio Inc

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Plantation

Florida

Location available
View Plantation location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Ann Arbor

Michigan

Location available
View Ann Arbor location page
RECRUITING

Arlington

Texas

Location available
View Arlington location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Scleroderma Treatment in La Jolla?

Join others in California exploring innovative treatment options through clinical research

Scleroderma Treatment Options in La Jolla, California

If you're searching for Scleroderma treatment in La Jolla, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in La Jolla, Plantation, Iowa City and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Scleroderma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 80 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Scleroderma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Scleroderma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Scleroderma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06843239. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.