Clinical trial of a single dose of treprostinil injected as a depot under the skin to investigate the effect on the digital blood flow and safety in patients with Raynaud’s Phenomenon due to Systemic Sclerosis

Phase 1

• Conditions: Raynaud’s phenomenon secondary to systemic sclerosis; MedDRA version: 20.0Level: PTClassification code 10037912Term: Raynaud's phenomenonSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-002444-24-GB
• Lead Sponsor: Camurus AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-18
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients with a diagnosis of systemic sclerosis, as defined by 2013 American College of Rheumatology (ACR) criteria / European League against Rheumatism (EULAR) criteria.

Patients with Raynaud’s phenomenon secondary to systemic sclerosis with a minimum of 5 Raynaud’s phenomenon attacks per week.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of active digital tip ulceration that has developed within 4 weeks before the Screening Visit. Active digital tip ulceration is defined by 1) visible loss of epithelial integrity or 2) an ulcer covered with eschar which is associated with ongoing moderate pain. Chronic ulcers with overlying eschar but with absent to mild pain are considered eligible.

A variability of more than ±20% between 2 assessments of thermography which are separated by at least 3 hours at the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified