A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis

• Status: Not yet recruiting
• Trial end date: 2022-09-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether oral temanogrel improves digital blood flow in participants with Raynaud's phenomenon secondary to systemic sclerosis (SSc-RP) as a potential safe and effective treatment for symptoms associated with SSc-RP.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals
• Treatments: APD791

Criteria

Inclusion Criteria:

• Raynaud's phenomenon (defined as a history of digital cold sensitivity associated with color changes of cyanosis and pallor, with on average at least 5 attacks per week during the winter period) secondary to systemic sclerosis (SSc)

• Both men and women participants agree to use a highly effective method of birth control if the possibility of conception exists

• Body mass index 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive

Exclusion Criteria:

• Active digital ulcer(s), recent history (within 3 months of Screening) of digital ulcers, or history of recurrent digital ulcerations that in the opinion of the Investigator increase the likelihood of developing a digital ulcer during the course of the study. Any history of gangrene, amputations, or other critical digital ischemic event

• Raynaud's phenomenon due to any cause other than SSc

• Severe gastrointestinal complications related to SSc that in the opinion of the Investigator could significantly affect study drug absorption

• History of gastrointestinal bleeding or active gastric or duodenal ulcers