AC-065C202: Raynaud’s Phenomenon secondary to Systemic Sclerosis
Research type
Research Study
Full title
A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud’s Phenomenon secondary to Systemic Sclerosis
IRAS ID
160819
Contact name
Christopher Denton
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd.
Eudract number
2014-000865-34
Research summary
Study AC-065C202 is a multi-centre, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud’s Phenomenon secondary to Systemic Sclerosis.
The study will involve participants aged 18 and over, who are suffering from Raynaud’s Phenomenon (RP) secondary to Systemic Sclerosis (Ssc). Systemic sclerosis is a rare disease that causes hardening and scarring of the skin and Raynaud’s Phenomenon is a condition in which smaller arteries that supply blood to the skin constrict, limiting blood circulation to areas such as the fingers and toes.
The main purpose of the study is to evaluate whether treatment with the study drug, selexipag, can reduce the number of Raynaud attacks experienced by participants. The study will also evaluate whether selexipag can reduce the burden of Raynaud’s Phenomenon on everyday life and how well the drug is tolerated in this patient group.
Raynaud’s Phenomenon worsens due to emotional stress and also during cold weather, therefore the study will be conducted during the six months of the cold season.
Study participation is expected to last up to 16 weeks for each patient, during which the participant will visit the study centre 4 times and be contacted 8 times by telephone.
As part of the study, participants will have their general health monitored and blood samples taken. They will be asked to complete a health questionnaire to assess their Ssc and its affect on their lives, and also to complete a daily electronic diary about any Raynaud attacks they experience.
The study will be performed at approximately 10 sites in 3 countries (UK, France, Germany) with approximately 70 participants in total.
REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/1461
Date of REC Opinion
16 Sep 2014
REC opinion
Further Information Favourable Opinion