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

NCT04915950

TerminatedPhase 2

Sponsor: Pfizer

Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis

Interventions: Temanogrel, Placebo

Countries: United States, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (6)

New Haven, Connecticut, United States
Baltimore, Maryland, United States
Pittsburgh, Pennsylvania, United States
Dundee, Scotland, United Kingdom
Bath, United Kingdom
Salford, United Kingdom