Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants (NCT NCT03870763)
NCT ID: NCT03870763
Last Updated: 2023-06-15
Results Overview
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Time to relapse is defined as from the first dose of the study drug to the day of relapse. Time to First Relapse is estimated by Kaplan Mayer method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
Baseline up to Week 96
Results posted on
2023-06-15
Participant Flow
Participants were enrolled at the investigative sites in Estonia, Tunisia, Turkey, Jordan and Taiwan from 19 March 2019 to 21 July 2022.
A total of 11 participants were enrolled and treated in this study.
Participant milestones
| Measure |
Dimethyl Fumarate 240 mg
Participants received dimethyl fumarate 120 milligrams (mg) capsules twice daily (BID), orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo subcutaneous (SC) injection once every 2 weeks (Q2W) for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
Participants received peginterferon beta-1a, 63 micrograms (µg) on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Dimethyl Fumarate 240 mg
Participants received dimethyl fumarate 120 milligrams (mg) capsules twice daily (BID), orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo subcutaneous (SC) injection once every 2 weeks (Q2W) for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
Participants received peginterferon beta-1a, 63 micrograms (µg) on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Overall Study
Study terminated by sponsor
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Worsening of multiple sclerosis attack
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
Baseline characteristics by cohort
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 2.12 • n=99 Participants
|
15.7 years
STANDARD_DEVIATION 1.51 • n=107 Participants
|
15.7 years
STANDARD_DEVIATION 1.15 • n=206 Participants
|
15.6 years
STANDARD_DEVIATION 1.36 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 96Population: ITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo).
A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. Time to relapse is defined as from the first dose of the study drug to the day of relapse. Time to First Relapse is estimated by Kaplan Mayer method.
Outcome measures
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Time to First Relapse
|
413 Days
Interval 413.0 to 413.0
|
NA Days
NA signifies data is not available as no participant in this arm group had a relapse.
|
166.5 Days
Interval 113.0 to 220.0
|
SECONDARY outcome
Timeframe: Baseline up to Week 100Population: Safety population included all participants who had received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: ITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo). The overall number of participants analyzed signifies number of participants analyzed in this endpoint and the number analyzed signifies number of participants analyzed at a given timepoint.
The number of new or newly enlarging T2 hyperintense lesions that developed in each participant assessed on magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=5 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
Week 48
|
0.5 number of lesions
Interval 0.0 to 1.0
|
1.0 number of lesions
Interval 0.0 to 3.0
|
3.3 number of lesions
Interval 2.0 to 4.0
|
|
Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 48 and 96
Week 96
|
2.5 number of lesions
Interval 0.0 to 5.0
|
1.3 number of lesions
Interval 0.0 to 3.0
|
3.5 number of lesions
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: ITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo). The overall number of participants analyzed signifies number of participants analyzed in this endpoint and the number analyzed signifies number of participants analyzed at a given timepoint.
The number of Gd-enhancing lesions was assessed by using MRI scans.
Outcome measures
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=5 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=2 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Number of Galdolinium (Gd)-Enhancing Lesions at Weeks 48 and 96
Week 48
|
0 number of lesions
Interval 0.0 to 0.0
|
0 number of lesions
Interval 0.0 to 0.0
|
1.5 number of lesions
Interval 0.0 to 3.0
|
|
Number of Galdolinium (Gd)-Enhancing Lesions at Weeks 48 and 96
Week 96
|
0 number of lesions
Interval 0.0 to 0.0
|
0.25 number of lesions
Interval 0.0 to 1.0
|
0.5 number of lesions
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Up to Week 96Population: ITT population included all participants who were randomized and received at least 1 dose of study treatment (BG00012, BIIB017, or placebo).
A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. The relapse rate for an individual participant was calculated as the number of relapses for that participant divided by the number of participant-years followed. The ARR for each enrolment group was calculated as the total number of relapses experienced in the group divided by the total number of participant-years on the study. An unadjusted relapse rate is reported.
Outcome measures
| Measure |
Dimethyl Fumarate 240 mg
n=2 Participants
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 Participants
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 Participants
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Annualized Relapse Rate
|
0.26 relapses per participant year
|
0.00 relapses per participant year
|
0.46 relapses per participant year
|
Adverse Events
Dimethyl Fumarate 240 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Peginterferon Beta-1a 125 µg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimethyl Fumarate 240 mg
n=2 participants at risk
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 participants at risk
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 participants at risk
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Dimethyl Fumarate 240 mg
n=2 participants at risk
Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
|
Peginterferon Beta-1a 125 µg
n=6 participants at risk
Participants received peginterferon beta-1a, 63 µg on Day 1, 94 µg at Week 2, 125 µg SC injection Q2W from Week 4 up to 96 weeks and peginterferon beta-1a matching placebo SC injection, Q2W for up to 96 weeks.
|
Placebo
n=3 participants at risk
Participants received peginterferon beta-1a matching placebo SC injection Q2W and dimethyl fumarate matching placebo capsules BID, orally for up to 96 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
2/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Infections and infestations
Vaginal infection
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Investigations
Parasite stool test positive
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
66.7%
4/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
66.7%
2/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
33.3%
1/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
1/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/2 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
16.7%
1/6 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
0.00%
0/3 • Baseline up to Week 100
Safety population included all participants who had received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER