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Diffuse Cutaneous Systemic SclerosisPhase 3BardSScNCT06936215

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

A Phase 3 study testing tab baricitinib 4 mg daily and tab methotrexate 25 mg weekly with folic acid 5 mg weekly in people with Diffuse Cutaneous Systemic Sclerosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions. It is divided into two types, limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSCc). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Cutaneous Systemic Sclerosis
What is being tested?
tab baricitinib 4 mg daily and tab methotrexate 25 mg weekly with folic acid 5 mg weekly
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBangladesh
Study dates
1 Jan 2024to May 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Subjects with any of the following characteristics/conditions will not be included in the study:
  • Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
  • Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
  • Major surgery (including joint surgery) within 8 weeks prior to screening visit
  • Any infected ulcer prior to treatment
  • Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
Show all 25Show fewer
  • Oral corticosteroids >10 mg/day of prednisone or equivalent.
  • Mycophenolate mofetil > 2 grams/day prior to baseline
  • Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
  • Current clinical, radiographic, or laboratory evidence of active TB.
  • Positive for hepatitis B surface antigen at or within 30 days of screening.
  • Positive for hepatitis C antigen at or within 30 days of screening.
  • Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
  • 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.
  • History of any malignancy in the last 5 years
  • History of SSc Renal Crisis within the 6 months prior to baseline.
  • Patients with a history of anaphylaxis to Baricitinib or methotrexate
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr Md. Fahad Hossain, MBBS, MD contact

+8801811237435

fhosen14@gmail.com

Dr Md. Ariful Islam, MBBS, MD, FCPS contact

+8801730053723

Bangladesh1 site, 1 recruiting

  • BSMMU

    Dhaka

    Fahad Hossain, MBBS, MD, +8801811237435, fhosen14@gmail.com

    Dr Ariful Islam, MBBS, FCPS, MD, +8801730053723, ariful_islam7400@yahoo.com

    Recruiting

Other trials in Bangladesh

About this study

Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions. It is divided into two types, limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSCc). Skin involvement in systemic sclerosis is assessed by modified Rodnan skin score (mRSS). Methotrexate is a drug used in the treatment of skin tightening in SSc but has inconsistent response . Janus kinase (JAK) inhibitors are a class of drugs that may be used in skin involvement in dcSSc. Among them, baricitinib, a JAK 1/2 inhibitor, has shown some efficacy in dcSSc. The aim of this study is to assess the efficacy and safety of baricitinib on skin tightening in dcSSc patients. This open label randomized clinical trial will be conducted in department of rheumatology, BSMMU. Systemic sclerosis will be diagnosed by ACR/EULAR classification criteria 2013. Among them who have diffuse cutaneous involvement will be considered primary entry criteria for this study. Consecutive sampling method will be applied. Participants will be divided into two groups, group A and group B. Group A will be put on tab. baricitinib 4 mg daily and group B will be put on tab. methotrexate 25 mg weekly with folic acid 5 mg weekly. All participants will be assessed for mRSS, CDAI at baseline and laboratory tests like CBC, ESR, CRP, SGPT, serum creatinine, CXR P/A view etc. Follow up will be done at 4, 12, 24 weeks. Response to treatment will be assessed by modified Rodnan skin score. Primary endpoint of efficacy will be assessed by the end of 24th week. adverse effects will be assessed by history, physical examination and investigations. The data will be analyzed by SPSS version 25. results will be recorded using means and standard deviations. Result will be compared among groups with a 95% confidence interval and a p-value 0f<0.05. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test for skewed distribution. Qualitative data in between groups will be analyzed by chi square test. Probabilities of association will be assessed by Spearman's rank correlation coefficient. P value of < 0.05 will be regarded as statistically significant.

Being tested
tab baricitinib 4 mg daily, tab methotrexate 25 mg weekly with folic acid 5 mg weekly
Keywords
Baricitinib in diffuse cutaneous systemic sclerosis
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tab baricitinib 4 mg dailyDrug

    Group A participants will be given tab. Baricitinib 4 mg daily

  • tab methotrexate 25 mg weekly with folic acid 5 mg weeklyDrug

    group A participants will be given tab. baricitinib 4 mg daily and group B participants will be given tab. methotrexate 25 mg weekly with folic acid 5 mg weekly

Study groups in NCT06936215
Study groupRoleWhat they receive
Group AExperimentalGroup A participants will get tab. baricitinib 4 mg daily
Receives: Drug: tab baricitinib 4 mg daily
Group BActive comparatorGroup B participants will be given tab. Methotrexate 25 mg weekly with folic acid 5 mg weekly
Receives: Drug: tab methotrexate 25 mg weekly with folic acid 5 mg weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in mRSS score

    mRSS score is recorded at baseline and change in mRSS score is measured in subsequent follow ups at 4, 12 and 24 weeks

    Measured: 24 weeks

Secondary outcomes (2)

  1. Change in CDAI score

    Baseline clinical disease activity index (CDAI) is recorded and is measured in subsequent follow ups at 4, 12 and 24 weeks

    Measured: 24 weeks

  2. See the side effects of drugs

    side effect of group A and group B is recorded at 4, 12 and 24 weeks

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start1 Jan 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06936215
Sponsor's protocol ID
5011
Acronym
BardSSc
Status last verified
Jan 2025
First submitted
12 Apr 2025
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: participants may not allow sharing all informations with others other than investigator

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tab baricitinib 4 mg daily and tab methotrexate 25 mg weekly with folic acid 5 mg weekly in people with Diffuse Cutaneous Systemic Sclerosis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Md. Fahad Hossain, MBBS, MD (+8801811237435, fhosen14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in mRSS score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06936215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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