Raynaud’s phenomenon secondary to systemic sclerosis MedDRA version: 20.0 Level: PT Classification code 10037912 Term: Raynaud's phenomenon System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: CAM2043
Product Code: CAM2043
Pharmaceutical Form: Prolonged-release solution for injection
INN or Proposed INN: Treprostinil Sodium
CAS Number: 289480-64-4
Current Sponsor code: CAM2043
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of a single subcutaneous (SC) dose of CAM2043 on skin temperature (an indirect measure of digital vascular perfusion), as evaluated by thermography following controlled cold challenge in patients with Raynaud’s phenomenon secondary to systemic sclerosis;Secondary Objective: To explore the effect of a single SC dose of CAM2043 on skin temperature To assess the pharmacokinetics (PK) of treprostinil following a single SC dose of CAM2043 to patients with Raynaud’s phenomenon secondary to systemic sclerosis To assess the effect of a single SC dose of CAM2043 on patient reported outcomes in patients with Raynaud’s phenomenon secondary to systemic sclerosis To explore the PK/pharmacodynamic (PD) relationships between treprostinil concentration and AUC and maximum skin temperature for thermography To assess the safety and tolerability of a single SC dose of CAM2043 in patients with Raynaud’s phenomenon secondary to systemic sclerosis ;Primary end point(s): - Change from Baseline to 6 h post-dose in the area under the curve (AUC) for reperfusion/rewarming (AUCtherm) as derived from thermography measurements;Timepoint(s) of evaluation of this end point: - 6 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Plasma concentrations of treprostinil - Change from baseline in Raynaud’s Condition Score - Change from baseline in Patient Global Assessment - Adverse events (AEs) - Clinical chemistry and hematology (including coagulation) - Urinalysis - Vital signs - Electrocardiogram (ECG);Timepoint(s) of evaluation of this end point: Days -14 to Day 0, Day 1, Day 2, Day 4, Day 8, Day 15 | — |
Countries
United Kingdom
Contacts
Public ContactClinical Development
Camurus AB
Outcome results
None listed