Trial Outcomes & Findings for ATX-MS-1467 in Multiple Sclerosis (NCT NCT01973491)
NCT ID: NCT01973491
Last Updated: 2017-07-02
Results Overview
T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.
COMPLETED
PHASE2
37 participants
Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)
2017-07-02
Participant Flow
37 subjects were enrolled in the study and entered the 8-week Baseline Control Period. Following completion of the Baseline Control Period, eligible subjects entered the 4-week Titration Period followed by a 16-week Treatment Period.
Participant milestones
| Measure |
ATX-MS-1467
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Baseline Control Period (8 Weeks)
STARTED
|
37
|
|
Baseline Control Period (8 Weeks)
COMPLETED
|
19
|
|
Baseline Control Period (8 Weeks)
NOT COMPLETED
|
18
|
|
Titration Period(4 Weeks)
STARTED
|
19
|
|
Titration Period(4 Weeks)
COMPLETED
|
19
|
|
Titration Period(4 Weeks)
NOT COMPLETED
|
0
|
|
Treatment Period (16 Weeks)
STARTED
|
19
|
|
Treatment Period (16 Weeks)
COMPLETED
|
18
|
|
Treatment Period (16 Weeks)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ATX-MS-1467
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Baseline Control Period (8 Weeks)
Did not meet Eligibility Criteria
|
17
|
|
Baseline Control Period (8 Weeks)
Withdrawal by Subject
|
1
|
|
Treatment Period (16 Weeks)
Adverse Event
|
1
|
Baseline Characteristics
ATX-MS-1467 in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 5.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)Population: The modified intention-to-treat (mITT) analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.
T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans
Baseline
|
7.4 lesions
Standard Deviation 7.62
|
|
Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans
Change Over Treatment Period
|
-2.4 lesions
Standard Deviation 4.37
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
The number of T1 CELs were measured using MRI scans.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 12
|
3.1 lesions
Standard Deviation 3.92
|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 16
|
4.6 lesions
Standard Deviation 6.26
|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 20
|
5.6 lesions
Standard Deviation 9.55
|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 24
|
4.9 lesions
Standard Deviation 11.07
|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 28
|
2.6 lesions
Standard Deviation 3.28
|
|
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Week 36
|
2.2 lesions
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 12
|
-3.0 lesions
Standard Deviation 4.90
|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 16
|
-2.8 lesions
Standard Deviation 5.20
|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 20
|
-1.6 lesions
Standard Deviation 5.11
|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 24
|
-2.2 lesions
Standard Deviation 7.10
|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 28
|
-4.2 lesions
Standard Deviation 7.06
|
|
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 36
|
-4.6 lesions
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Baseline
|
0.838 milliliter
Standard Deviation 1.0151
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 12
|
-0.321 milliliter
Standard Deviation 0.5618
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 16
|
-0.316 milliliter
Standard Deviation 0.7184
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 20
|
-0.225 milliliter
Standard Deviation 0.7845
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 24
|
-0.333 milliliter
Standard Deviation 0.8622
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 28
|
-0.454 milliliter
Standard Deviation 0.9403
|
|
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 36
|
-0.579 milliliter
Standard Deviation 0.8807
|
SECONDARY outcome
Timeframe: Weeks 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
T2 lesions were measured using MRI scans.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 12
|
14.7 lesions
Standard Deviation 20.69
|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 16
|
4.5 lesions
Standard Deviation 6.16
|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 20
|
5.4 lesions
Standard Deviation 10.07
|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 24
|
4.9 lesions
Standard Deviation 8.27
|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 28
|
2.6 lesions
Standard Deviation 3.28
|
|
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions
Week 36
|
4.2 lesions
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: Week 0, 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
T1 CELs were measured using MRI scans.
Outcome measures
| Measure |
ATX-MS-1467
n=18 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Week 0
|
7.2 lesions
Standard Deviation 6.71
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 12
|
-3.4 lesions
Standard Deviation 6.67
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 16
|
-2.3 lesions
Standard Deviation 7.03
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 20
|
-0.9 lesions
Standard Deviation 8.57
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 24
|
-1.5 lesions
Standard Deviation 10.87
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 28
|
-3.1 lesions
Standard Deviation 5.04
|
|
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 36
|
-3.5 lesions
Standard Deviation 4.40
|
SECONDARY outcome
Timeframe: Weeks 0, 12, 16, 20, 24, 28 and 36Population: The mITT analysis set. Here, "Number of participants analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
T1 CELs were measured using MRI scans.
Outcome measures
| Measure |
ATX-MS-1467
n=18 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 12
|
-0.420 milliliter
Standard Deviation 0.7520
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Week 0
|
0.815 milliliter
Standard Deviation 0.8121
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 16
|
-0.264 milliliter
Standard Deviation 0.7737
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 20
|
-0.157 milliliter
Standard Deviation 0.9839
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 24
|
-0.271 milliliter
Standard Deviation 1.4318
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 28
|
-0.341 milliliter
Standard Deviation 0.4541
|
|
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Change at Week 36
|
-0.473 milliliter
Standard Deviation 0.5914
|
SECONDARY outcome
Timeframe: Week 20Population: Analysis population included subset of mITT analysis set who had relapse.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).
Outcome measures
| Measure |
ATX-MS-1467
n=3 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Mean Annualized Relapse Rate
|
2.60 relapse per year
Standard Deviation 0.011
|
SECONDARY outcome
Timeframe: Baseline up to Week 36Population: The mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Time to First Relapse
|
NA days
Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 95% CI were not estimable since very few subjects had relapse during the study.
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 20Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
EDSS is an ordinal scale in half-point increments that qualifies disability in subjects with Multiple Sclerosis. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as any other neurological findings due to Multiple Sclerosis. Total EDSS score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20
Baseline (Week 0)
|
2.32 units on a scale
Standard Deviation 0.803
|
|
Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20
Change at Week 20
|
-0.11 units on a scale
Standard Deviation 0.916
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Week 20Population: The mITT analysis set. Here, "Number Analyzed" signifies those subjects who were evaluable at the specified time point.
The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20
Baseline (Week 0)
|
0.001 Z-score
Standard Deviation 0.7215
|
|
Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20
Change at Week 20
|
0.187 Z-score
Standard Deviation 0.4321
|
SECONDARY outcome
Timeframe: Baseline up to Week 25Population: The SAF Analysis Set included all subjects who received at least 1 dose of IMP.
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the current study. TEAEs include both Serious TEAEs and non-serious TEAEs.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAEs
|
15 subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
Serious TEAEs
|
0 subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAEs Leading to Death
|
0 subjects
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation
TEAEs Leading to Discontinuation
|
1 subjects
|
SECONDARY outcome
Timeframe: Baseline up to Week 22Population: The SAF Analysis Set included all subjects who received at least 1 dose of IMP.
Treatment-emergent ISRs were defined as any ISR with a start date on or after the date of first dose and within 7 days after the date of last dose in the current study. Injection site reactions were identified as erythema, induration, pruritus, nodules and/or cysts, ecchymosis, pain and local edema.
Outcome measures
| Measure |
ATX-MS-1467
n=19 Participants
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Number of Subjects Experiencing Injection Site Reactions (ISRs)
|
7 subjects
|
Adverse Events
ATX-MS-1467
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ATX-MS-1467
n=19 participants at risk
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.8%
3/19 • Baseline up to Week 25
|
|
Infections and infestations
Cervicitis
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Respiratory tract infection viral
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Vaginitis gardnerella
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Viral infection
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Vulvovaginal candidiasis
|
5.3%
1/19 • Baseline up to Week 25
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
1/19 • Baseline up to Week 25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
5.3%
1/19 • Baseline up to Week 25
|
|
Blood and lymphatic system disorders
Eosinophilia
|
5.3%
1/19 • Baseline up to Week 25
|
|
Blood and lymphatic system disorders
Neutrophilia
|
5.3%
1/19 • Baseline up to Week 25
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Baseline up to Week 25
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Baseline up to Week 25
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
2/19 • Baseline up to Week 25
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Baseline up to Week 25
|
|
Gastrointestinal disorders
Enterocolitis
|
5.3%
1/19 • Baseline up to Week 25
|
|
Gastrointestinal disorders
Gastritis
|
5.3%
1/19 • Baseline up to Week 25
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Baseline up to Week 25
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
10.5%
2/19 • Baseline up to Week 25
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Baseline up to Week 25
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Baseline up to Week 25
|
|
General disorders
Injection site erythema
|
26.3%
5/19 • Baseline up to Week 25
|
|
General disorders
Injection site induration
|
10.5%
2/19 • Baseline up to Week 25
|
|
General disorders
Injection site pain
|
10.5%
2/19 • Baseline up to Week 25
|
|
General disorders
Injection site pruritus
|
10.5%
2/19 • Baseline up to Week 25
|
|
General disorders
Injection site haemorrhage
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Lymphocyte count decreased
|
10.5%
2/19 • Baseline up to Week 25
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Monocyte count decreased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Monocyte percentage decreased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Neutrophil count increased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Reticulocyte count decreased
|
5.3%
1/19 • Baseline up to Week 25
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Baseline up to Week 25
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place