Back to resultsA Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Primary Purpose
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Temanogrel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Raynaud's Phenomenon Secondary to Systemic Sclerosis focused on measuring Raynaud's phenomenon, SSc-RP, Systemic sclerosis, SSc, Digital cold sensitivity, Digital blood flow, APD791, Temanogrel
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
Sites / Locations
- Yale University
- Johns Hopkins Asthma and Allergy Center
- UPMC Arthritis and Auotimmune Clinic
- Ninewells Hospital & Medical School
- Royal United Hospitals Bath
- Salford Royal Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
Temanogrel (Stage A Dose 1)
Temanogrel (Stage A Dose 2)
Placebo (Stage A)
Temanogrel (Stage B Dose 1)
Temanogrel (Stage B Dose 2)
Placebo (Stage B)
Arm Description
Outcomes
Primary Outcome Measures
Rewarming Area Under the Curve (AUC) as Assessed With Infrared (IR) Thermography
Reperfusion AUC as Assessed With Laser Speckle Contrast Imaging (LSCI)
Secondary Outcome Measures
Maximum Reduction Following a Cold Challenge as Assessed With IR Thermography
Maximum Reduction Following a Cold Challenge as Assessed With LSCI
Maximum Recovery During the 30 Minutes Following a Cold Challenge as Assessed With IR Thermography
Maximum Recovery During the 30 Minutes Following a Cold Challenge as Assessed With LSCI
AUC During the Initial 2 Minutes Following a Cold Challenge as Assessed With IR Thermography
AUC During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI
Slope During the Initial 2 Minutes Following a Cold Challenge as Assessed With IR Thermography
Slope During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI
Time to Achieve 50% Recovery From the Cold Challenge-induced Reduction as Assessed With IR Thermography
Time to Achieve 50% Recovery From the Cold Challenge-induced Reduction as Assessed With LSCI
Time to Achieve 70% Recovery From the Cold Challenge-induced Reduction as Assessed With IR Thermography
Time to Achieve 70% Recovery From the Cold Challenge-induced Reduction as Assessed With LSCI
Change From Predose to Postdose in Room Temperature Values as Assessed With IR Thermography
Change From Predose to Postdose in Room Temperature Values as Assessed With LSCI
Change From Predose to Postdose in Distal Dorsal Difference (DDD), Assessed With IR Thermography
DDD is defined as the difference in measurements between the dorsum and the finger at room temperature
Change From Predose to Postdose in DDD as Assessed With LSCI
DDD is defined as the difference in measurements between the dorsum and the finger at room temperature
Number and Severity of Adverse Events
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04915950
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Keywords
Raynaud's phenomenon, SSc-RP, Systemic sclerosis, SSc, Digital cold sensitivity, Digital blood flow, APD791, Temanogrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Temanogrel (Stage A Dose 1)
Arm Type
Experimental
Arm Title
Temanogrel (Stage A Dose 2)
Arm Type
Experimental
Arm Title
Placebo (Stage A)
Arm Type
Placebo Comparator
Arm Title
Temanogrel (Stage B Dose 1)
Arm Type
Experimental
Arm Title
Temanogrel (Stage B Dose 2)
Arm Type
Experimental
Arm Title
Placebo (Stage B)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Temanogrel
Other Intervention Name(s)
APD791
Intervention Description
Participants will receive a single oral dose of temanogrel during the treatment visit.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.
Primary Outcome Measure Information:
Title
Rewarming Area Under the Curve (AUC) as Assessed With Infrared (IR) Thermography
Time Frame
Up to 30 minutes following a cold challenge
Title
Reperfusion AUC as Assessed With Laser Speckle Contrast Imaging (LSCI)
Time Frame
Up to 30 minutes following a cold challenge
Secondary Outcome Measure Information:
Title
Maximum Reduction Following a Cold Challenge as Assessed With IR Thermography
Time Frame
Up to 30 minutes following a cold challenge
Title
Maximum Reduction Following a Cold Challenge as Assessed With LSCI
Time Frame
Up to 30 minutes following a cold challenge
Title
Maximum Recovery During the 30 Minutes Following a Cold Challenge as Assessed With IR Thermography
Time Frame
Up to 30 minutes following a cold challenge
Title
Maximum Recovery During the 30 Minutes Following a Cold Challenge as Assessed With LSCI
Time Frame
Up to 30 minutes following a cold challenge
Title
AUC During the Initial 2 Minutes Following a Cold Challenge as Assessed With IR Thermography
Time Frame
Up to 2 minutes following a cold challenge
Title
AUC During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI
Time Frame
Up to 2 minutes following a cold challenge
Title
Slope During the Initial 2 Minutes Following a Cold Challenge as Assessed With IR Thermography
Time Frame
Up to 2 minutes following a cold challenge
Title
Slope During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI
Time Frame
Up to 2 minutes following a cold challenge
Title
Time to Achieve 50% Recovery From the Cold Challenge-induced Reduction as Assessed With IR Thermography
Time Frame
Up to 30 minutes following a cold challenge
Title
Time to Achieve 50% Recovery From the Cold Challenge-induced Reduction as Assessed With LSCI
Time Frame
Up to 30 minutes following a cold challenge
Title
Time to Achieve 70% Recovery From the Cold Challenge-induced Reduction as Assessed With IR Thermography
Time Frame
Up to 30 minutes following a cold challenge
Title
Time to Achieve 70% Recovery From the Cold Challenge-induced Reduction as Assessed With LSCI
Time Frame
Up to 30 minutes following a cold challenge
Title
Change From Predose to Postdose in Room Temperature Values as Assessed With IR Thermography
Time Frame
Predose for 5 minutes at room temperature and at Postdose prior to cold challenge for 5 minutes at room temperature
Title
Change From Predose to Postdose in Room Temperature Values as Assessed With LSCI
Time Frame
Predose for 5 minutes at room temperature and at Postdose prior to cold challenge for 5 minutes at room temperature
Title
Change From Predose to Postdose in Distal Dorsal Difference (DDD), Assessed With IR Thermography
Description
DDD is defined as the difference in measurements between the dorsum and the finger at room temperature
Time Frame
Predose for 5 minutes at room temperature and at Postdose prior to cold challenge for 5 minutes at room temperature
Title
Change From Predose to Postdose in DDD as Assessed With LSCI
Description
DDD is defined as the difference in measurements between the dorsum and the finger at room temperature
Time Frame
Predose for 5 minutes at room temperature and at Postdose prior to cold challenge for 5 minutes at room temperature
Title
Number and Severity of Adverse Events
Description
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time Frame
Study Day 1 through approximately 47 days for each stage of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Johns Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
UPMC Arthritis and Auotimmune Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Ninewells Hospital & Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal United Hospitals Bath
City
Bath
ZIP/Postal Code
BAI 3NG
Country
United Kingdom
Facility Name
Salford Royal Hospital
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Effect of Oral Temanogrel on Digital Blood Flow in Adult Participants With Raynaud's Phenomenon Secondary to Systemic Sclerosis
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