Status:
TERMINATED
A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arena is a wholly owned subsidiary of Pfizer
Conditions:
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
The study will be conducted in 2 stages: Stage A and Stage B. In both stages, participants will be equally randomized in a double-blind manner to a 3-period crossover treatment sequence. Separate coho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04915950
Start Date
November 3 2021
End Date
September 2 2022
Last Update
December 22 2023
Active Locations (6)
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1
Yale University
New Haven, Connecticut, United States, 06519
2
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
3
UPMC Arthritis and Auotimmune Clinic
Pittsburgh, Pennsylvania, United States, 15213
4
Ninewells Hospital & Medical School
Dundee, Scotland, United Kingdom, DD1 9SY