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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis

Treatments: Drug: Temanogrel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04915950

APD791-204

C5071001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 6 patient groups, including a placebo group

Temanogrel (Stage A Dose 1)

Experimental group

Treatment:

Drug: Temanogrel

Temanogrel (Stage A Dose 2)

Experimental group

Treatment:

Drug: Temanogrel

Placebo (Stage A)

Placebo Comparator group

Treatment:

Drug: Placebo

Temanogrel (Stage B Dose 1)

Experimental group

Treatment:

Drug: Temanogrel

Temanogrel (Stage B Dose 2)

Experimental group

Treatment:

Drug: Temanogrel

Placebo (Stage B)

Placebo Comparator group

Treatment:

Drug: Placebo