A study of PRA023 in patients with Systemic Sclerosis Associated with Interstitial Lung Disease

Phase 1

• Conditions: Systemic sclerosis associated with interstitial lung disease; MedDRA version: 21.0Level: LLTClassification code 10025109Term: Lung involvement in systemic sclerosisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-005206-10-IT
• Lead Sponsor: Prometheus Biosciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-17
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Confirmed diagnosis of systemic sclerosis with onset of disease < or =5 years ago
2. Diffuse cutaneous scleroderma
3. Systemic sclerosis related to interstitial lung disease confirmed by HRCT
4. FVC > or = 45% of predicted normal
5. Diffusing capacity of lung for carbon monoxide (DLCO) > or = 45% of predicted normal
6. Stable dosing of myocphenolate mofetil (MMF), methotrexate (MTX) or azathioprine, as well as corticosteroids
7. Able to provide written informed consent and understand and comply with the requirements of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. WOCBP and men with female partners of childbearing potential who are unwilling or unable to use two highly effective methods of contraception to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of study drug.
2. Airway obstruction per pulmonary function test (PFT) or Clinically significant pulmonary arterial hypertension.
3. Current clinical diagnosis of another inflammatory connective tissue disease
disease
4. Any active infections, a serious infection within the past 3 months, or chronic bacterial infection
5. Current smoker or smoking within 6 months of screening
6. Subjects in the opinion of the investigator that are at an unacceptable risk for participation in the study
7. Subjects who meet the protocol criteria for important laboratory exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified