Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

NCT ID: NCT02260557

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

Conditions

Raynaud's Phenomenon Secondary to Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Selexipag

Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD.

Group Type: EXPERIMENTAL

Selexipag

Intervention Type: DRUG

Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily

Placebo

Placebo matching selexipag tablets is administered according to the same schedule as selexipag

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo matching selexipag 200 μg tablets to be administered orally twice daily

Interventions

Selexipag

Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily

Intervention Type: DRUG

Placebo

Placebo matching selexipag 200 μg tablets to be administered orally twice daily

Intervention Type: DRUG

Other Intervention Names

ACT-293987

Eligibility Criteria

Inclusion Criteria

• Signed informed consent prior to any study-mandated procedure.
• Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
• Women of childbearing potential must agree to use a reliable method of birth control.

Exclusion Criteria

• Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
• Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
• Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
• Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
• Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
• Severe renal insufficiency (at randomization).
• Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Preiss, MD

Role: STUDY_CHAIR

Actelion

References

Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.

Reference Type: DERIVED

PMID: 29193819 (View on PubMed)

Other Identifiers

AC-065C202

Identifier Type: -

Identifier Source: org_study_id