Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis
Keywords: Raynaud's phenomenon
SSc-RP
Systemic sclerosis
SSc
Digital cold sensitivity
Digital blood flow
APD791
Temanogrel
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2021-06-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Change in Digital Blood Flow Based on Rewarming Area Under the Curve (AUC) During Thirty Minutes Following a Cold Challenge
timeFrame: 30 minutes following a cold challenge
measure: Change in Digital Blood Flow Based on Reperfusion AUC During the Thirty Minutes Following a Cold Challenge
timeFrame: 30 minutes following a cold challenge
Secondary outcomes:
measure: Maximum Reduction in Temperature Following a Cold Challenge Assessed With Infrared (IR) Thermography
timeFrame: 30 minutes following a cold challenge
measure: Maximum Reduction in Perfusion Temperature Following a Cold Challenge With Laser Speckle Contrast Imaging (LSCI)
timeFrame: 30 minutes following a cold challenge
measure: Maximum Recovery in Temperature Following a Cold Challenge Assessed With IR Thermography
timeFrame: 30 minutes following a cold challenge
measure: Maximum Recovery in Perfusion Temperature Following a Cold Challenge Assessed With LSCI
timeFrame: 30 minutes following a cold challenge
measure: AUC During the Initial Two Minutes Following a Cold Challenge Assessed With IR Thermography
timeFrame: Initial 2 minutes following a cold challenge
measure: Perfusion AUC During the Initial Two Minutes Following a Cold Challenge Assessed With LSCI
timeFrame: Initial 2 minutes following a cold challenge
measure: Slope During the Initial 2 Minutes (120 Seconds) Following a Cold Challenge Assessed With IR Thermography
timeFrame: Initial 2 minutes following a cold challenge
measure: Perfusion Slope During the Initial 2 Minutes (120 Seconds) Following a Cold Challenge Assessed With LSCI
timeFrame: Initial 2 minutes following a cold challenge
measure: Time to Achieve 50 Percent (%) Recovery From the Cold Challenge-Induced Reduction Assessed With IR Thermography and With LSCI
timeFrame: 30 minutes following a cold challenge
measure: Time to Achieve 70 % Recovery From the Cold Challenge-Induced Reduction Assessed With IR Thermography and With LSCI
timeFrame: 30 minutes following a cold challenge
measure: Change From Predose to Post-dose in Room Temperature Values as Assessed With IR Thermography
timeFrame: 5 minutes pre-dose, 5 minutes post-dose
measure: Change From Predose to Post-dose in Room Temperature Perfusion Values as Assessed With LSCI
timeFrame: 5 minutes pre-dose, 5 minutes post-dose
measure: Change From Predose to Post-dose in Distal Dorsal Difference (DDD), Assessed With IR Thermography
timeFrame: 5 minutes pre-dose, 5 minutes post-dose
measure: Change From Predose to Post-dose in Distal Dorsal Difference (DDD) [Perfusion], Assessed With LSCI
timeFrame: 5 minutes pre-dose, 5 minutes post-dose
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Day 1 of dose to maximum of 4 (+/-1) days after last dose (up to maximum of 22 days)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
city: Pittsburgh
country: United States
facility: UPMC Arthritis and Auotimmune Clinic
state: Pennsylvania
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
state: Scotland
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: