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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

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ClinicalTrials.gov Identifier: NCT04915950
Recruitment Status : Terminated (Business decision)
First Posted : June 7, 2021
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Secondary to Systemic Sclerosis Drug: Temanogrel Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 3, 2021
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : September 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Temanogrel (Stage A Dose 1) Drug: Temanogrel
Participants will receive a single oral dose of temanogrel during the treatment visit.
Other Name: APD791
Experimental: Temanogrel (Stage A Dose 2) Drug: Temanogrel
Participants will receive a single oral dose of temanogrel during the treatment visit.
Other Name: APD791
Placebo Comparator: Placebo (Stage A) Drug: Placebo
Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.
Experimental: Temanogrel (Stage B Dose 1) Drug: Temanogrel
Participants will receive a single oral dose of temanogrel during the treatment visit.
Other Name: APD791
Experimental: Temanogrel (Stage B Dose 2) Drug: Temanogrel
Participants will receive a single oral dose of temanogrel during the treatment visit.
Other Name: APD791
Placebo Comparator: Placebo (Stage B) Drug: Placebo
Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.


Outcome Measures
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Primary Outcome Measures :
  1. Rewarming Area Under the Curve (AUC) as Assessed With Infrared (IR) Thermography [ Time Frame: Up to 30 minutes following a cold challenge ]
  2. Reperfusion AUC as Assessed With Laser Speckle Contrast Imaging (LSCI) [ Time Frame: Up to 30 minutes following a cold challenge ]

Secondary Outcome Measures :
  1. Maximum Reduction Following a Cold Challenge as Assessed With IR Thermography [ Time Frame: Up to 30 minutes following a cold challenge ]
  2. Maximum Reduction Following a Cold Challenge as Assessed With LSCI [ Time Frame: Up to 30 minutes following a cold challenge ]
  3. 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 ]
  4. Maximum Recovery During the 30 Minutes Following a Cold Challenge as Assessed With LSCI [ Time Frame: Up to 30 minutes following a cold challenge ]
  5. 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 ]
  6. AUC During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI [ Time Frame: Up to 2 minutes following a cold challenge ]
  7. 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 ]
  8. Slope During the Initial 2 Minutes Following a Cold Challenge as Assessed With LSCI [ Time Frame: Up to 2 minutes following a cold challenge ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. Change From Predose to Postdose in Distal Dorsal Difference (DDD), 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 ]
    DDD is defined as the difference in measurements between the dorsum and the finger at room temperature

  16. Change From Predose to Postdose in DDD 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 ]
    DDD is defined as the difference in measurements between the dorsum and the finger at room temperature

  17. Number and Severity of Adverse Events [ Time Frame: Study Day 1 through approximately 47 days for each stage of the study ]
    Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915950


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
United States, Pennsylvania
UPMC Arthritis and Auotimmune Clinic
Pittsburgh, Pennsylvania, United States, 15213
United Kingdom
Ninewells Hospital & Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Royal United Hospitals Bath
Bath, United Kingdom, BAI 3NG
Salford Royal Hospital
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
More Information
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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04915950    
Other Study ID Numbers: APD791-204
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
Raynaud's phenomenon
SSc-RP
Systemic sclerosis
SSc
 Digital cold sensitivity
Digital blood flow
APD791
Temanogrel
Additional relevant MeSH terms:
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Neoplasm Metastasis
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Neoplastic Processes
Neoplasms
Connective Tissue Diseases
Skin Diseases
 Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
APD791
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs