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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04915950
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Arena Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arena CT.gov Administrator
Principal Investigator Affiliation	Arena Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Raynaud's Phenomenon Secondary to Systemic Sclerosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Temanogrel (Stage A Dose 1)

Experimental: Temanogrel (Stage A Dose 2)

Placebo Comparator: Placebo (Stage A)

Experimental: Temanogrel (Stage B Dose 1)

Experimental: Temanogrel (Stage B Dose 2)

Placebo Comparator: Placebo (Stage B)

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06519

Site Contact

[email protected]

+1 855-218-9153

Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland

Status

Recruiting