Clinical Trials

Inclusion Criteria:

• Male or female ≥18 years of age at time of informed consent.

• Classification of SSc as defined by the 2013 American College of Rheumatology/EULAR criteria.

• Diagnosis or history of RP, self-reported or reported by a physician, with at least a 2- phase color change in finger(s) of pallor, cyanosis, and/or reactive hyperemia in response to cold exposure or emotion.

• Participants must have a minimum of 12 (maximum of 100) symptomatic RP attacks, documented in the ePRO diary over 4 separate days during a 5-day eligibility period

  • Note: A symptomatic attack for this study is defined as at least 1 color change of the participant’s finger(s) (white, blue, and/or red) associated with pain, numbness, and/or tingling of the finger(s). The attack is considered over when the color changes back to pre-attack color and the symptom returns to the participant’s pre-attack level. Participants must complete

Exclusion Criteria:

• Participants with 3 or more digital ulcers at screening.

• Participants who develop a new digital ulcer(s) after screening and prior to randomization.

• Participants with a gangrene, or amputation within 6 months of randomization.

• Participants with a digital ulcer infection within 3 months of randomization.

• Participants with history of cervical or digital sympathectomy, or botulism toxin injections in their hands (for RP or digital ulcers) within 90 days of screening. Participants should not have a planned botulism toxin or sympathectomy during their participation in the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/08/2026. Questions regarding updates should be directed to the study team contact.