Learn about a New Systemic Sclerosis Clinical Trial for Your Patients

The TibuSURE study aims to assess the effect of tibulizumab on skin thickness in patients with systemic sclerosis (SSc) and lung involvement and function in patients with SSc-ILD.

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The TibuSURE Study

The purpose of this phase 2 study is to determine whether tibulizumab reduces skin thickness and disease severity in patients with systemic sclerosis.

Participants must meet the following criteria:
Are between 18 and 70 years old
Have SSc, according to the American College of Rheumatology (ACR) and the European Alliance of Association for Rheumatology (EULAR) 2013 criteria
Have 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
Have had SSc (first non-RP symptom or sign attributed to SSc) for ≤5 years at time of informed consent
Have a body mass index (BMI) between 18 and 35 kg/m2
Participants are not eligible if they:
Have any current rheumatic disease other than SSc (such as rheumatoid arthritis, polymyalgia rheumatica, systemic lupus erythematosus, and polymyositis/dermatomyositis) that may interfere with assessment of SSc
Have had a renal crisis in the last 6 months
Have lung disease requiring continuous oxygen therapy
Have active Crohn’s Disease or ulcerative colitis
Used a B-cell depleting medication within the last year (prior to investigational drug dosing)  
Initiated the antifibrotics nintedanib or pirfenidone within the last 6 months (prior to investigational drug dosing)  

Other eligibility criteria apply and will be evaluated by a principal investigator.

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Participants will be expected to:

Visit the study site 17 times over 15 months where they will be given 2 injections once every two weeks for the first month and every four weeks after.
There is a 50% chance that participants will receive a placebo during the first period of the study (20 week treatment period).
This study includes an open-label extension period during which participants will receive the active study drug, tibulizumab.
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What the TibuSURE Study Offers

The study aims to discover whether tibulizumab may slow disease activity and progression in the skin and lungs of systemic sclerosis patients.
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By enrolling in this phase 2 study, participants may receive:  

The investigational study drug at no cost. Insurance is not required to join this study.  

Reimbursements for travel and accommodations related to study visits.

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Next Steps

If you have a patient who may be interested in this study and may be eligible, you can:  

Complete the “Contact PatientWing” form below. We’ll contact you and discuss how your patient can get involved.

Share this study with your patient so they can apply on their own. Provide them with this website For Patients & Loved Ones so they can read about the study and fill out a pre-screen questionnaire.

If you have patients who may be a good fit for the study, please contact PatientWing!

Contact PatientWing

If you have a patient who may be eligible, we would love to speak with you! Please submit the information below so our team can reach out. There is no obligation to you or your patient, by submitting this form.  
Call Us
213-459-2979
Email Us
studies@patientwing.com
Do you have a patient who may be a good fit for this study?
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Our mission is to transform the lives of those living with severe autoimmune and inflammatory conditions by aiming to deliver breakthrough treatments that offer real hope and lasting impact.
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Tibulizumab is an investigational agent, meaning that its efficacy and safety have not been established by any regulatory agency worldwide.
A clinical study for people with systemic sclerosis.
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