Is NCT06195072 recruiting in Birmingham, AL?

Yes, NCT06195072 is currently recruiting participants at its Birmingham, AL location. This scleroderma clinical trial is actively enrolling qualified participants.

How do I join the scleroderma clinical trial in Birmingham?

To join this clinical trial in Birmingham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Birmingham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Scleroderma Clinical Trial in Birmingham, AL

About This Scleroderma Study in Birmingham

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

Sponsor: Scleroderma Research Foundation, Inc.

Who Can Participate

Inclusion Criteria

Male or female 18+ years of age at the time of signed informed consent;

SSc classification as defined by the 2013 American College of Rheumatology/European League Against Rheumatism criteria. Participants with diffuse, limited or sine cutaneous skin involvement are eligible

Onset of SSc (defined by first non-Raynaud's symptom) 7 years or less prior to the Screening Visit;

A Modified Rodnan skin score (mRSS) less than 40

Presence of ILD with evidence of any fibrosis on HRCT (within 3 months or less of randomization)

Presence of an FVC 45% or more predicted normal;

Presence of a diffusing capacity of the lung for carbon monoxide (DLCO) 30% or more predicted normal, corrected for hemoglobin; Other protocol and/or subprotocol inclusion criteria apply.

Exclusion Criteria

Presence of clinically significant pulmonary abnormalities inconsistent with ILD on HRCT (e.g., scarring due to previous active tuberculosis \[TB\], sarcoidosis, lung mass, or other findings unrelated to SSc-ILD, as determined by a local radiologist/Investigator);

Presence of infected ulcers or active gangrene at the Screening Visit;

History of scleroderma renal crisis within 6 months prior to the Screening Visit;

Forced expiratory volume in 1 second/FVC \<0.65 (pre-bronchodilator) at the Screening Visit

History of stem cell transplantation, bone marrow transplantation, chimeric antigen receptor T-cell therapy, or solid organ transplantation;

History of treatment with rituximab within the 6 months prior to the Screening Visit;

History treatment with cell-depleting therapies other than rituximab, including, but not limited to, CAMPATH®; anti-cluster of differentiation (CD)3, anti-CD4, anti-CD5, antiCD19, and anti-CD20 agents; and investigational agents

Treatment with tocilizumab, nintedanib, pirfenidone, abatacept, leflunomide, tacrolimus, tofacitinib, intravenous immunoglobulin (IVIG), or any biologic or cyclophosphamide within 3 months prior to Screening Visit

History of use of any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer) prior to Screening Visit.

Presence of any of the following laboratory findings at the Screening Visit:

Estimated glomerular filtration rate \<45 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration equation;

Alanine aminotransferase or aspartate aminotransferase level \> (2 x ULN);

Platelets \<100 × 109/L (100,000/μL);

White blood cell count \<2500/μL;

Neutrophil blood count \<1500/μL;

Prothrombin time and partial thromboplastin time \>1.5 × ULN, or international normalized ratio \>2; or

Any other laboratory test result, that in the opinion of the Investigator, might place the study participant at risk for participation in the study.

Presence of a clinically significant disorder that, in the opinion of the Investigator, could contraindicate the administration of study product, affect compliance, interfere with study evaluations, or confound the interpretation of study results

Presence of a concomitant life-threatening disease with life expectancy \<12 months based on the Investigator's assessment;

Evidence of active tuberculosis (TB) or being at high risk for TB Other protocol and/or subprotocol exclusion criteria apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT06195072) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Scleroderma Treatment Options in Birmingham, AL

If you're searching for scleroderma treatment options in Birmingham, AL, this clinical trial (NCT06195072) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced scleroderma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all scleroderma clinical trials near you to find additional studies recruiting in your area.

Scleroderma Clinical Trial in Birmingham, AL

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