Phase 2
N=69
A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis
Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04744207 ↗Enrolled (actual)
69
Serious AEs
1.5%
Results posted
Aug 2024
Primary outcome: Primary: Mean Change From Baseline to Week 4 in the Number of Raynaud Attacks Per Week. — -3.41; -4.22 number of attacks — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GS-248 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gesynta Pharma AB
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 4 in the Number of Raynaud Attacks Per Week. |
-3.41; -4.22 | <0.05 sig |
| SECONDARY Mean Change From Baseline to Week 4 in the Raynaud's Condition Score. |
-0.99; -0.95 | — |
| SECONDARY Mean Change From Baseline to Week 4 in Pain Experienced During Raynaud Attacks. |
-0.65; -0.60 | — |
| SECONDARY Mean Change From Baseline to Week 4 in the Mean Duration of Raynaud's Attacks |
1.06; 0.89 | — |
| SECONDARY Mean Change From Baseline to Week 4 in the Cumulative Duration of Raynaud Attacks. |
0.70; 0.61 | — |
Summary
The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).
Eligibility Criteria
Inclusion Criteria
- Subjects must provide signed and dated written informed consent before the conduct of any study-specific procedures.
- Male and female subjects aged 18-75 years inclusive.
- Systemic Sclerosis diagnosed according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria (van den Hoogen F et al. 2013). Subjects with signs of other autoimmune diseases (e.g. Sjögren's syndrome, myositis, rheumatoid arthritis) could be included if SSc is the dominating phenotype.
- Raynaud attacks typically ≥7 times per week during the last 4 weeks prior to screening despite background medication (only allowed vasodilatory therapy is calcium channel blockers or PDE-5 inhibitors).
- Women of childbearing potential must be using a highly effective method of contraception to avoid pregnancy throughout the study and for 4 weeks after the last dose of Investigational Medicinal Product in such manner that the risk of pregnancy is minimised.
- Women must not be pregnant or breastfeeding.
- Male subjects to agree to use condom in combination with use of contraceptive methods with a failure rate of 450 msec.
- Creatinine clearance <50 mL/min (determined by Cockcroft-Gault equation) at Screening.
- Active digital ulcer (DU) within 4 weeks prior to Visit 1.
- Clinically meaningful laboratory abnormalities at Screening (Visit 1), as determined and documented by the Investigator.
Data sourced from ClinicalTrials.gov (NCT04744207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.