Effectiveness and safety of riociguat in patients with sclerosis of the ski

Phase 1

• Conditions: diffuse cutaneous systemic sclerosis (dcSSc); MedDRA version: 17.1 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-001353-16-HU
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1.Written informed consent
2. Men or women aged 18 years and older
3. Systemic sclerosis, as defined by ACR/EULAR 2013 criteria
4. dcSSc according to the LeRoy criteria
5. Disease duration of = 18 months (defined as time from the first non-Raynaud’s phenomenon manifestation)
6. = 10 and = 22 mRSS units at the screening visit
7. FVC = 45% of predicted at screening
8. DLCO = 40% of predicted (hemoglobin-corrected) at screening
9. Negative serum pregnancy test in a woman of childbearing potential at the screening visit
10. Women of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception” is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.
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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Limited cutaneous SSc at screening
2. Major surgery (including joint surgery) within 8 weeks prior to screening
3. Hepatic insufficiency classified as Child-Pugh C
4. Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit
- Because the MDRD formula is thought to cause significant bias for Japanese patients, the equation for Japanese patients is: 194 x serum creatinine (mg/dL) -1.094 x Age -0.287 x 0.739 (if female).
5. Any prior history of renal crisis
6. Sitting SBP < 95 mmHg at the screening visit
7. Sitting heart rate < 50 beats per minute (BPM) at the screening visit
8. Left ventricular ejection fraction < 40% prior to screening
9. Diagnosed PAH as determined by right heart catheterization
10. Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening
11. Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
12. Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
13. Not permitted prior and concomitant medication
14. pregnant or breast feeding women
15. Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.

Study & Design

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