* Ph2 study to assess temanogrel in patients with Raynaud's phenomenon
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Subjects with Raynaud’s Phenomenon Secondary to Systemic Sclerosis
IRAS ID
294849
Contact name
Ariane Herrick
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc.
Eudract number
2021-001355-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
The proposed study plans to assess the effects of temanogrel (APD791) on blood flow in the hands of patients with Raynaud's phenomenon who also have systemic sclerosis. Raynaud’s phenomenon is characterised as an exaggerated vascular response to cold temperature or emotional stress, resulting in decreased blood flow to extremities, more commonly in fingers and toes. Temanogrel is an oral medication designed to prevent the narrowing of blood vessels, therefore it is hoped that blood flow will be maintained, and the risk of Raynaud’s attacks is minimised.
The study will be conducted in 2 stages (Stage A and Stage B). Approximately 24 patients will be enrolled in stage A. Across 3 treatment visits, participants will receive placebo, 60 mg temanogrel, and 120 mg temanogrel. Participants will receive one of these doses at each treatment visit, the order in which they receive them will be random. Participants will undergo blood tests, physical examinations, cold challenges and blood flow tests to measure any changes in blood flow following treatment with temanagorel.Once stage A is complete, 24 new participants will be recruited for Stage B. The study treatment assignment will be random, the same as in Stage A. Participants will receive placebo and two other doses of temanaogrel, the doses of temanogrel to be administered in stage B will be determined from the results of stage A. Participants will be evaluated using the same study design applied in Stage A.
Overall, study participation is expected to be approximately 6-7 weeks for each participant. 48 adult participants are planned to enrol in this study across sites in the United Kingdom and United States.
Summary of Results:
: No efficacy or primary endpoint analysis was conducted due to early termination of the study, which was unrelated to safety.
Arithmetic mean temanogrel plasma concentrations associated at 120 mg were higher than those following a 60 mg dose. Mean metabolite concentrations of each metabolite were lower than temanogrel. Overall safety profile of temanogrel appeared to be favorable in this study, with higher incidence of Treatment emergent adverse events (TEAEs) observed in the placebo group compared to temanogrel treatment groups and no notable changes in laboratory, vital signs, or ECGs were observed.REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0316
Date of REC Opinion
7 May 2021
REC opinion
Further Information Favourable Opinion