Clinical Trial Results:
A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)
Summary
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EudraCT number |
2020-002081-13 |
Trial protocol |
GB NL BE PL |
Global end of trial date |
15 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
05 May 2023
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First version publication date |
05 May 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS-2001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04744207 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Gesynta Pharma AB
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Sponsor organisation address |
Wallingatan-24, Stockholm, Sweden, SE-111 24
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Public contact |
Clinical Information Point, Gesynta Pharma AB, ClinicalInformation@gesynta.se
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Scientific contact |
Clinical Information Point, Gesynta Pharma AB, ClinicalInformation@gesynta.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Oct 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Jun 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Jun 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.
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Protection of trial subjects |
The first IMP administration was taken at the study site, under the supervision of the study staff. Patients were closely followed with regular safety blood samples taken, patients were asked about any adverse events at each visit and IMP accountability was checked at each visit.
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Background therapy |
Subjects were permitted the following background vasodilatory treatment; Ca-blockers or PDE-5 inhibitors. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
29 Dec 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 9
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Country: Number of subjects enrolled |
Poland: 43
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Country: Number of subjects enrolled |
United Kingdom: 37
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Country: Number of subjects enrolled |
Belgium: 5
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Worldwide total number of subjects |
94
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EEA total number of subjects |
57
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
83
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
In addition to fulfilling all eligibility criteria, subjects must fulfil the following criteria to be randomised: • ≥7 RP attacks during the last week of the run-in period as captured in the eDiary, with no more than 2 days without RP attacks. • Compliance with the eDiary during the 7 most recent days prior to baseline (Visit 2), excluding the vi | ||||||||||||||||||
Pre-assignment
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Screening details |
The run-in period was 14-21 days prior to Day 1, Baseline visit (the first dose of IMP). | ||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
94 | ||||||||||||||||||
Number of subjects completed |
69 | ||||||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 2 | ||||||||||||||||||
Reason: Number of subjects |
Violated inclusion/exclusion: 23 | ||||||||||||||||||
Period 1
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Period 1 title |
Treatment
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Subject | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GS-248 | ||||||||||||||||||
Arm description |
Allocated to receive active treatment, GS-248 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
GS-248
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
GS-248, supplied as 40mg capsules. Each single dose consisted of 3 capsules constituting a total of 120mg.
The initial dose of IMP (120 mg once daily) was taken at the study site at Visit 2 under supervision of the investigator or qualified staff. Subsequent doses of IMP were self-administered by the subject, taken orally, once daily. The final dose of IMP was taken at the study site (Visit 4).
The IMP was administered with water, in the morning with food.
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Placebo arm | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo, supplied as capsules identical to GS-248.
The initial dose of placebo (3 capsules) was taken at the study site at Visit 2 under supervision of the investigator or qualified staff. Subsequent doses of placebo were self-administered by the subject, taken orally, once daily. The final dose of placebo was taken at the study site (Visit 4).
The placebo was administered with water, in the morning with food.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The number of patients enrolled worldwide is all patients who signed the ICF but the number of subjects in the baseline period is those who completed the pre-assignment period and were randomised. |
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Period 2
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Period 2 title |
Follow-Up
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GS-248 | ||||||||||||||||||
Arm description |
Follow-up of those allocated to receive active treatment, GS-248 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
GS-248
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Not applicable, no treatment was received during follow-up period
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Follow-up of those randomised to placebo arm | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Not applicable as no treatment received during follow-up period.
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Baseline characteristics reporting groups
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Reporting group title |
GS-248
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Reporting group description |
Allocated to receive active treatment, GS-248 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
FAS - GS-248
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects that were randomised to receive GS-248 and received at least one dose
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Subject analysis set title |
PPS - GS-248
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Per Protocol Set (PPS) encompassed all subjects randomized to receive GS-248 of the FAS who had no major protocol deviations that affected the evaluation of the effect of GS-248 on the primary endpoint as determined during the blinded data review meeting (BDRM).
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Subject analysis set title |
SAS - GS-248
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Analysis Set (SAS) consisted of all subjects who were randomised to receive GS-248 and administered GS-248 at least once
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Subject analysis set title |
FAS - placebo
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects that were randomised to receive placebo and received at least one dose.
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Subject analysis set title |
PPS - placebo
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Per Protocol Set (PPS) encompassed all subjects randomized to receive placebo of the FAS who had no major protocol deviations that affected the evaluation of the effect of placebo on the primary endpoint as determined during the blinded data review meeting (BDRM).
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Subject analysis set title |
SAS - placebo
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety Analysis Set (SAS) consisted of all subjects who were randomised to receive placebo and administered the placebo at least once
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End points reporting groups
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Reporting group title |
GS-248
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Reporting group description |
Allocated to receive active treatment, GS-248 | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo arm | ||
Reporting group title |
GS-248
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Reporting group description |
Follow-up of those allocated to receive active treatment, GS-248 | ||
Reporting group title |
Placebo
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Reporting group description |
Follow-up of those randomised to placebo arm | ||
Subject analysis set title |
FAS - GS-248
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects that were randomised to receive GS-248 and received at least one dose
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Subject analysis set title |
PPS - GS-248
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per Protocol Set (PPS) encompassed all subjects randomized to receive GS-248 of the FAS who had no major protocol deviations that affected the evaluation of the effect of GS-248 on the primary endpoint as determined during the blinded data review meeting (BDRM).
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Subject analysis set title |
SAS - GS-248
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Analysis Set (SAS) consisted of all subjects who were randomised to receive GS-248 and administered GS-248 at least once
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Subject analysis set title |
FAS - placebo
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects that were randomised to receive placebo and received at least one dose.
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Subject analysis set title |
PPS - placebo
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per Protocol Set (PPS) encompassed all subjects randomized to receive placebo of the FAS who had no major protocol deviations that affected the evaluation of the effect of placebo on the primary endpoint as determined during the blinded data review meeting (BDRM).
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Subject analysis set title |
SAS - placebo
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Analysis Set (SAS) consisted of all subjects who were randomised to receive placebo and administered the placebo at least once
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End point title |
Mean change from baseline to week 4 in the number of RP attacks per week. | ||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively.
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Statistical analysis title |
Primary endpoint analysis | ||||||||||||||||||||
Statistical analysis description |
ANCOVA model for change from baseline to visit 4 (week 4) including the stratification factor (vasodilatory treatment) and treatment as fixed factors and baseline levels as a covariate. The placebo multiple imputation (pMI) method was used for replacement of missing data.
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Comparison groups |
FAS - GS-248 v FAS - placebo
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Parameter type |
Least square means estimate | ||||||||||||||||||||
Point estimate |
0.81
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-2.48 | ||||||||||||||||||||
upper limit |
4.1 | ||||||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
0.628
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Notes [1] - The primary objective was to be met if there was a p-value <0.05 with a numerical superior efficacy of the active group versus placebo with regard to the primary endpoint, i.e., the mean change (reduction) in RP attacks that is greater in the active group. |
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End point title |
Mean change from baseline to week 4 in the Raynaud’s Condition Score | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively.
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No statistical analyses for this end point |
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End point title |
Mean change from baseline to week 4 in the cumulative duration of RP attacks. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively.
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No statistical analyses for this end point |
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End point title |
Mean change from baseline to week 4 in pain experienced during RP attacks. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively.
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No statistical analyses for this end point |
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End point title |
Mean change from baseline to week 4 in the mean duration of RP attacks | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively.
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
All SAEs and AEs were to be collected from the signing of the ICF until the follow-up visit (Visit 5)
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Adverse event reporting additional description |
An AE that occurs from first IMP dose until 7 days after last IMP dose was considered a Treatment Emergent AE regardless of the assessed relationship to the IMP. All other AEs reported after signed ICF but outside of the period specified above were considered non-treatment emergent.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.0
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Reporting groups
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Reporting group title |
GS-248
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Reporting group description |
Actually received GS-248 during the study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Actually received placebo during study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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15 Jul 2020 |
The protocol has been updated to reflect following changes and for some minor administrative and clarification changes, including to the exclusion criteria.
Secondary efficacy endpoints were updated:
- Mean change from baseline to week 4 in peripheral blood flow prior to cold challenge and IMP administration.
- Mean change in peripheral blood flow from pre-IMP to post-IMP administration at Visit 2.
- Mean change from baseline to week 4 in recovery of peripheral blood flow after cold challenge
- Number of countries was updated for the conduct of the study.
- Study assessment was updated to include PK sampling
- Removed the inclusion criteria related to finger temperature
- Exclusion Criterion for Cold Challenge was added
- Definition of Prolonged QTcF interval was updated |
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01 Sep 2020 |
The protocol has been updated following requests from the MHRA and for some minor administrative changes
WOCBP and Highly Effective Contraception was updated based on the request from MHRA
WOCBP given home pregnancy test to be used 35-40 days after their last dose of IMP (Visit 4).
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25 Mar 2021 |
The protocol has been updated to reflect following changes and for some minor administrative and clarification changes, including to the exclusion criteria.
- Visit 4, End of Treatment Visit, occurred on Day 28 (-2/+1 days), which was the day subjects took their final dose of IMP, to be administered at the study site
- Mean change in recovery of peripheral blood flow after cold challenge from pre-IMP to post-IMP administration at Visit 2.
- A COVID-19 vaccination considered a permitted concomitant medication and is therefore not contraindicated for use with GS-248.
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10 Dec 2021 |
The protocol has been updated to reflect emerging data on GS-248 interaction with moderate and strong CYP3A4 inhibitors resulting in an additional exclusion criterion and addition of prohibited concomitant medications. Changes in the descriptions of analyses populations as well as some minor administrative updates have also been made.
A safety measure added relating to results from a drug-drug interaction (DDI) clinical study with GS-248.
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |