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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

NCT ID: NCT04915950

Last Updated: 2023-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-09-02

Brief Summary

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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

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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

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Raynaud's Phenomenon Secondary to Systemic Sclerosis

Keywords

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Raynaud's phenomenon SSc-RP Systemic sclerosis SSc Digital cold sensitivity Digital blood flow APD791 Temanogrel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Temanogrel (Stage A Dose 1)

Group Type EXPERIMENTAL

Temanogrel

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel during the treatment visit.

Temanogrel (Stage A Dose 2)

Group Type EXPERIMENTAL

Temanogrel

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel during the treatment visit.

Placebo (Stage A)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.

Temanogrel (Stage B Dose 1)

Group Type EXPERIMENTAL

Temanogrel

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel during the treatment visit.

Temanogrel (Stage B Dose 2)

Group Type EXPERIMENTAL

Temanogrel

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel during the treatment visit.

Placebo (Stage B)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.

Interventions

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Temanogrel

Participants will receive a single oral dose of temanogrel during the treatment visit.

Intervention Type DRUG

Placebo

Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.

Intervention Type DRUG

Other Intervention Names

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APD791

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arena is a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Site Status

UPMC Arthritis and Auotimmune Clinic

Pittsburgh, Pennsylvania, United States

Site Status

Ninewells Hospital & Medical School

Dundee, Scotland, United Kingdom

Site Status

Royal United Hospitals Bath

Bath, , United Kingdom

Site Status

Salford Royal Hospital

Salford, , United Kingdom

Site Status

Countries

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United States United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=APD791-204

To obtain contact information for a study center near you, click here.

Other Identifiers

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C5071001

Identifier Type: OTHER

Identifier Source: secondary_id

APD791-204

Identifier Type: -

Identifier Source: org_study_id