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

NCT02260557 | Completed Phase 2

• 1 other identifier: AC-065C202
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Keywords

Systemic Sclerosis; Raynaud's Phenomenon

Outcome Measures

Primary Outcomes (1)

• Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period

  The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).

  From Day 26 to Day 56 ( +/- 7 days)

Secondary Outcomes (2)

• Number of patients with treatment-emergent adverse events

  Up to end of study (Day 86 +/- 7 days)

• Number of patients with treatment-emergent serious adverse events

  Up to end of study (Day 86 +/- 7 days)

Other Outcomes (1)

• Change from baseline in quality of life (QOL)

  At baseline (Day 1) and end of treatment (Day 56 +/- 7 days)

Study Arms (2)

Selexipag

EXPERIMENTAL

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.

Drug: Selexipag

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Selexipag DRUG

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

Also known as: ACT-293987

Selexipag

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Related Publications (1)

• 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.

  PMID: 29193819 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Raynaud Disease

Interventions

selexipag

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Study Officials

• Ralph Preiss, MD

  Actelion

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 3, 2025

Record last verified: 2025-01