Evaluating Baricitinib for Skin Tightening in Systemic Sclerosis

Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

This study is testing if a new medication called baricitinib can help improve skin tightness in people with diffuse cutaneous systemic sclerosis compared to a standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Academic / other)
• Drugs / interventions: Baricitinib, methotrexate, prednisone
• Locations: 1 site (Dhaka)
• Trial ID: NCT06936215 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of baricitinib, a JAK inhibitor, in treating skin tightening associated with diffuse cutaneous systemic sclerosis (dcSSc). Participants will be randomly assigned to receive either baricitinib or methotrexate, a traditional treatment for this condition. The study aims to assess changes in skin involvement using the modified Rodnan skin score (mRSS) over a specified period. It is an open-label trial conducted at Bangabandhu Sheikh Mujib Medical University in Dhaka, Bangladesh.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with diffuse cutaneous systemic sclerosis who meet specific inclusion criteria, including a baseline mRSS score of 10 or higher.

Not a fit: Patients with limited cutaneous systemic sclerosis or other rheumatic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for managing skin tightening in patients with diffuse cutaneous systemic sclerosis.

How similar studies have performed: While the use of JAK inhibitors like baricitinib in systemic sclerosis is promising, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 1\. Diagnosis of diffuse cutaneous systemic sclerosis, as classified using the 2013 American College of Rheumatology

  2\. Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger 3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation) 4. mRSS score ≥ 10 at baseline

Exclusion Criteria:

Subjects with any of the following characteristics/conditions will not be included in the study:

1. Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
4. Any infected ulcer prior to treatment
5. Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
6. Oral corticosteroids \>10 mg/day of prednisone or equivalent.
7. Mycophenolate mofetil \> 2 grams/day prior to baseline
8. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
9. Current clinical, radiographic, or laboratory evidence of active TB.
10. Positive for hepatitis B surface antigen at or within 30 days of screening.
11. Positive for hepatitis C antigen at or within 30 days of screening.
12. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
13. Pregnant or breastfeeding female subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after discontinuation of study drug.
14. History of any malignancy in the last 5 years
15. History of SSc Renal Crisis within the 6 months prior to baseline.
16. Patients with a history of anaphylaxis to Baricitinib or methotrexate
17. Any of the following lab results at screening:

    * Hemoglobin \<8 g/dl
    * White Blood Cell count \<3.0 x 109/L;
    * Absolute Neutrophil count \<1.2 x 109/L;
    * Platelet count \<100 x 109/L;
    * Absolute Lymphocyte count \<0.75 x 109/L.
    * ALT \> 3 × the upper limit of normal (ULN) of normal at screening
    * Estimated glomerular filtration rate \[GFR\] \<60mL/min/1.73 m2

Where this trial is running

Dhaka

• Bsmmu — Dhaka, Bangladesh (Recruiting)

Study contacts

• Principal investigator: Dr MD. Fahad Hossain, MBBS, MD — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Study coordinator: Dr Md. Fahad Hossain, MBBS, MD

Conditions Diffuse Cutaneous Systemic Sclerosis; Baricitinib in diffuse cutaneous systemic sclerosis