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Phase 2 N=27 Treatment

Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis

Systemic Sclerosis, Scleroderma

Bottom Line

View on ClinicalTrials.gov: NCT00613171 ↗
Enrolled (actual)
27
Serious AEs
18.5%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis — 25.7; 6.58; 5.97; 8.34 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
STI571 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis		 25.7; 6.58; 5.97; 8.34; 8.48; 3.34 —
PRIMARY
Number of Participants With Adverse Events (AE's) and Serious Adverse Events (SAE's)		 27; 5 —
SECONDARY
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values		 27; 0; 0; 0; 25; 2 —

Summary

This study investigates the efficacy and safety of STI571 for the treatment of fibrosis in participants with systemic sclerosis. Other purposes of the study were to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis participants' gut was also investigated by testing the drug level in the blood (pharmacokinetics).

Eligibility Criteria

Inclusion Criteria

  • Male and female participants who are equal to or older than 18 years of age and who have early diffuse cutaneous systemic sclerosis (Disease duration < 18 months from the first non-Raynaud's symptom)
  • Participants with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence of trunk involvement or a MRSS of at least 16 in patients with trunk involvement
  • Female patients of childbearing potential practicing two acceptable forms of contraception

Exclusion Criteria

  • SSc patients with a MRSS greater than 35
  • Concurrent connective tissue diseases other than systemic sclerosis
  • Significant pre-existing heart, liver, lungs, digestive system, blood and other diseases, cancer
  • Conditions that might mimic the potential side effects of STI571 (blood conditions, liver damage, chronic diarrhea, edema)
  • Concurrent medical therapies (or during last 6 weeks before first dosing) that may potentially influence outcome of the study
  • Allergic to the study medication
  • Pregnancy
  • Breast feeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00613171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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