Is NCT07287670 recruiting in Newport Beach, CA?

Yes, NCT07287670 is currently recruiting participants at its Newport Beach, CA location. This diffuse cutaneous systemic sclerosis clinical trial is actively enrolling qualified participants.

Is participation in this Newport Beach 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.

Diffuse Cutaneous Systemic Sclerosis Clinical Trial in Newport Beach, CA

Q: How do I join the diffuse cutaneous systemic sclerosis clinical trial in Newport Beach?

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

Who Can Participate

Inclusion Criteria

Diagnosis of diffuse cutaneous systemic sclerosis, classified according to 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)

Participant is either:

Within 2 years of their first non-Raynaud's symptom and their mRSS is \>7; OR

\>2 and ≤5 years from their first non-Raynaud's symptom, their mRSS is between 10 and 30, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS on exams performed by the same clinician, or (2) they were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done; OR

\>5 and ≤10 years from their first non-Raynaud's symptom, their mRSS is between \>15 and ≤25, they are negative for the RNA polymerase 3 autoantibody, and (1) they have never had any previous spontaneous improvement in skin thickening of ≥4 points by mRSS, or (2) were never clinically noted to have a meaningful spontaneous reduction in skin thickness if mRSS was never done.

Participant is ≥18 years of age at time of signing the ICF.

Able to understand the study and provide a signed, written ICF

Able to read and understand the language of the ICF and other study-related materials

Forced vital capacity (FVCpp) of ≥45 pp10

Have diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥30 percent predicted at Screening

Willing and able to complete all protocol-required study visits and procedures

Participants of childbearing potential must have a negative serum pregnancy test at Screening.

All participants with reproductive potential must agree to use and follow medically approved, highly effective methods of contraception during treatment and until 5 half-lives or 125 days after the last dose, whichever is longer

Exclusion Criteria

Concomitantly have another serious medical illness, which, in the opinion of the Investigator, would interfere with the participant's ability to complete the study

Participant is currently on immunosuppressive therapy, systemic glucocorticoids or other antifibrotic agents detailed as follows:

Immunosuppresive agents: Cyclophosphamide (IV or oral if used in the 6 months prior to Screening), calcineurin inhibitors (if used in the 30 days prior to Screening), azathioprine (if used in the 30 days prior to Screening), Janus-kinase inhibitors (if used in the 30 days prior to Screening), rituximab (if used in the 6 months prior to Screening), tocilizumab (if used in the 60 days prior to Screening) or any other biologic Disease-Modifying Antirheumatic Drugs (DMARD, if used in the last 30 days or 3 half-lives prior to Screening, whichever is longer)

Antifibrotic agents: nintedanib or pirfenidone (if used in the 30 days prior to Screening). Also, exclusionary if used within 3 months of Screening are tyrosine-kinase inhibitors with recognized anti-fibrotic activity (imatinib, nilotinib, etc.)

Systemic glucocorticoids: equivalent doses of prednisone greater than 10 mg/day (≤10 mg/day allowed). Has received any pulse intramuscular (IM) or intravenous (IV) steroid within 1 month of Screening

Other agents: i. mycophenolate mofetil unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; ii. mycophenolic acid unless on a stable dose for at least 6 months prior to Screening and there are no plans to adjust the dose during the study; iii. hydroxychloroquine unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study; and iv. methotrexate unless on a stable dose for at least 3 months prior to Screening and there are no plans to adjust the dose during the study.

Previous or planned hematopoietic stem cell or solid organ transplantation

Previous treatment with chimeric antigen receptor (CAR)-T/CAR-NK therapy

Clinically significant PAH as determined by the Investigator at, or prior to first day of dosing (Baseline)

Current use of PAH medication (endothelin receptor antagonists, prostacyclin analogues, soluble guanylate cyclase stimulators) excluding calcium channel blockers and phosphodiesterase-5 inhibitors

Pregnant or currently breastfeeding

Aspartate transaminase (AST) or alanine transaminase (ALT) \>2.0 upper limit of normal

Creatinine clearance \<45mL/min

History of myocardial infarction, angina or congestive heart failure

International normalized ratio \>2 or partial thromboplastin time \>1.5 × upper limit of normal

Active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

History of clinically significant thrombotic event within 12 months prior to Screening

Positive anticentromere antibody

Systemic sclerosis renal crisis within 12 months prior to Screening

Confirmed diagnosis of overlap syndrome, systemic lupus erythematosus with anti-double strand (ds)DNA antibody, rheumatoid arthritis with anti-cyclic citrullinated peptide (anti-CCP) antibody, or systemic sclerosis mimics (eosinophilic fasciitis, scleromyxedema) at the time of inclusion in the study

Known malignancy or history of malignancy within 5 years of Screening other than non-melanoma skin cancer and in situ cervical cancer

Major surgery within 8 weeks prior to Screening or planned surgery during study period

Unable to routinely access veins for blood draws and IV infusions

Currently receiving another experimental agent or participating in another clinical trial. If a participant has recently received another experimental agent, then the last dose must have been at least 5 half-lives or 30 days (whichever is longer) prior to Screening

History of myocardial infarction, angina or congestive heart failure

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 Newport Beach?

Yes, this clinical trial (NCT07287670) has an active research site in Newport Beach, CA 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.

Diffuse Cutaneous Systemic Sclerosis Treatment Options in Newport Beach, CA

If you're searching for diffuse cutaneous systemic sclerosis treatment options in Newport Beach, CA, this clinical trial (NCT07287670) 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 Newport Beach research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diffuse cutaneous systemic sclerosis 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 diffuse cutaneous systemic sclerosis clinical trials near you to find additional studies recruiting in your area.

Diffuse Cutaneous Systemic Sclerosis Clinical Trial in Newport Beach, CA

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