NCT04915950

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 cohorts of participants will participate in each stage. In Stage A, participants will be treated with two dose levels of temanogrel and placebo. Doses in Stage B will be determined based on the results of Stage A.

Conditions

• Raynaud's Phenomenon Secondary to Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Temanogrel	Participants will receive a single oral dose of temanogrel during the treatment visit.
DRUG	Placebo	Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2021-06-07
• Last updated: 2023-12-22
• Results posted: 2023-12-22

Locations

6 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study