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Platelet Aggregation Inhibitor

Temanogrel (Stage A Dose 1) for Raynaud's Phenomenon

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of dose to maximum of 4 (+/-1) days after last dose (up to maximum of 22 days)
Awards & highlights

Study 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.

Eligible Conditions
  • Raynaud's Phenomenon

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of dose to maximum of 4 (+/-1) days after last dose (up to maximum of 22 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dose to maximum of 4 (+/-1) days after last dose (up to maximum of 22 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Digital Blood Flow Based on Reperfusion AUC During the Thirty Minutes Following a Cold Challenge
Change in Digital Blood Flow Based on Rewarming Area Under the Curve (AUC) During Thirty Minutes Following a Cold Challenge
Secondary outcome measures
AUC During the Initial Two Minutes Following a Cold Challenge Assessed With IR Thermography
Change From Predose to Post-dose in Distal Dorsal Difference (DDD) [Perfusion], Assessed With LSCI
Change From Predose to Post-dose in Distal Dorsal Difference (DDD), Assessed With IR Thermography
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Temanogrel (Stage B Dose 2)Experimental Treatment1 Intervention
Group II: Temanogrel (Stage B Dose 1)Experimental Treatment1 Intervention
Group III: Temanogrel (Stage A Dose 2)Experimental Treatment1 Intervention
Group IV: Temanogrel (Stage A Dose 1)Experimental Treatment1 Intervention
Group V: Placebo (Stage A)Placebo Group1 Intervention
Group VI: Placebo (Stage B)Placebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Arena is a wholly owned subsidiary of PfizerIndustry Sponsor
10 Previous Clinical Trials
2,632 Total Patients Enrolled
PfizerLead Sponsor
4,560 Previous Clinical Trials
10,907,171 Total Patients Enrolled
1 Trials studying Raynaud's Phenomenon
243 Patients Enrolled for Raynaud's Phenomenon
Arena PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
5,863 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025