Trial Outcomes & Findings for A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG) (NCT NCT05681715)
NCT ID: NCT05681715
Last Updated: 2025-11-06
Results Overview
Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Week 12 (last dose of Self-administration Period 1)
Results posted on
2025-11-06
Participant Flow
The study started to enroll participants in April 2023 and concluded in April 2024.
Participant Flow refers to Safety Set (SS) for Training Period and Randomized Safety Set (RSS) for Self-administration Periods 1 and 2.
Participant milestones
| Measure |
All Participants: Training Period
All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization.
|
Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP)
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with MP once every week from Week 13 to 18 during Self-administration Period 2. Study has no wash-out period.
|
Sequence 2: RLZ MP - RLZ SRD
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with SRD once every week from Week 13 to 18 during Self-administration Period 2. Study had no wash-out period.
|
|---|---|---|---|
|
Training Period (6-weeks)
STARTED
|
62
|
0
|
0
|
|
Training Period (6-weeks)
COMPLETED
|
55
|
0
|
0
|
|
Training Period (6-weeks)
NOT COMPLETED
|
7
|
0
|
0
|
|
Self-administration Period 1 (6 Weeks)
STARTED
|
0
|
28
|
27
|
|
Self-administration Period 1 (6 Weeks)
COMPLETED
|
0
|
23
|
26
|
|
Self-administration Period 1 (6 Weeks)
NOT COMPLETED
|
0
|
5
|
1
|
|
Self-administration Period 2 (6 Weeks)
STARTED
|
0
|
25
|
26
|
|
Self-administration Period 2 (6 Weeks)
COMPLETED
|
0
|
25
|
26
|
|
Self-administration Period 2 (6 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
All Participants: Training Period
All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization.
|
Sequence 1: RLZ Syringe Driver (SRD) - RLZ Manual Push (MP)
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with MP once every week from Week 13 to 18 during Self-administration Period 2. Study has no wash-out period.
|
Sequence 2: RLZ MP - RLZ SRD
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1 followed by RLZ administered subcutaneously with SRD once every week from Week 13 to 18 during Self-administration Period 2. Study had no wash-out period.
|
|---|---|---|---|
|
Training Period (6-weeks)
Adverse Event
|
3
|
0
|
0
|
|
Training Period (6-weeks)
Consent withdrawn by participant (not due to AE)
|
1
|
0
|
0
|
|
Training Period (6-weeks)
Not Eligible for SA but continued in study
|
3
|
0
|
0
|
|
Self-administration Period 1 (6 Weeks)
Diagnosis change to amyotrophic lateral sclerosis
|
0
|
1
|
0
|
|
Self-administration Period 1 (6 Weeks)
Consent withdrawn by participant (not due to AE)
|
0
|
0
|
1
|
|
Self-administration Period 1 (6 Weeks)
Adverse Event
|
0
|
1
|
0
|
|
Self-administration Period 1 (6 Weeks)
Participant became ineligible for SA
|
0
|
1
|
0
|
|
Self-administration Period 1 (6 Weeks)
Missed infusion at Visit 13, SA Period1 incomplete
|
0
|
2
|
0
|
Baseline Characteristics
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
Baseline characteristics by cohort
| Measure |
All Participants: Training Period
n=62 Participants
All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization.
|
|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 15.7 • n=49 Participants
|
|
Age, Customized
18 - <65 years
|
45 Participants
n=49 Participants
|
|
Age, Customized
65 - <85 years
|
17 Participants
n=49 Participants
|
|
Age, Customized
>=85 years
|
0 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
White
|
55 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
1 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
57 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: Week 12 (last dose of Self-administration Period 1)Population: The Full Analysis Set (FAS) consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme.
Successful self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose.
Outcome measures
| Measure |
Period 1: RLZ SRD
n=18 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 1: RLZ MP
n=23 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 2: RLZ SRD
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2.
|
Period 2: RLZ MP
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2.
|
RLZ Total
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 13 (Week 12)
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 18 (last dose of Self-administration Period 2)Population: FAS consisted of all participants who were included in SS, were randomized, and completed both self-administration periods in accordance with the randomization scheme.
Successful Self-administration was defined by the participant (i) choosing the correct infusion site, (ii) administering SC, and (iii) delivering the intended dose.
Outcome measures
| Measure |
Period 1: RLZ SRD
n=23 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 1: RLZ MP
n=18 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 2: RLZ SRD
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2.
|
Period 2: RLZ MP
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2.
|
RLZ Total
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Successful Self-administration of Rozanolixizumab (With Correct Use of Syringe Driver and Manual Push, Respectively) During the Self-administration Period at Visit 19 (Week 18)
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 1 up to the End of Study Visit (Week 26)Population: SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). The Randomized Safety Set (RSS) consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE starting on or after the date of first administration of rozanolixizumab in the study, up to and including 8 weeks (56 days) after the final dose.
Outcome measures
| Measure |
Period 1: RLZ SRD
n=28 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 1: RLZ MP
n=27 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 2: RLZ SRD
n=26 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2.
|
Period 2: RLZ MP
n=26 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2.
|
RLZ Total
n=62 Participants
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) After Syringe Driver or Manual Push Self-administration From Visit 2 (Week 1) up to the End of Study Visit (Visit 21 [Week 26])
|
35.7 percentage of participants
|
29.6 percentage of participants
|
26.9 percentage of participants
|
38.5 percentage of participants
|
75.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 hours after each administration during the Training Period (Baseline to Week 6) and Self-administration Periods (Week 7 to Week 18)Population: SS included all study participants who received at least 1 dose of investigational medicinal product (partial or full). Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
The local site reactions up to 24 hours after each administration were defined as AEs reported as local site reactions as per case report form within one day after RLZ administration.
Outcome measures
| Measure |
Period 1: RLZ SRD
n=62 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 1: RLZ MP
n=28 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 2: RLZ SRD
n=27 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2.
|
Period 2: RLZ MP
n=26 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2.
|
RLZ Total
n=26 Participants
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Local Site Reactions up to 24 Hours After Each Administration During the Training Period and Self-administration Periods
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the Self-administration Periods (Week 7 to Week 18)Population: RSS consisted of all participants who were included in SS and were randomized. Here, number of participants analyzed included those participants who were evaluable for the outcome measure.
Medication errors were defined as an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the study participant. Medication Errors associated with adverse reactions during the 2 Self-administration Periods were measured.
Outcome measures
| Measure |
Period 1: RLZ SRD
n=28 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 1: RLZ MP
n=27 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 7 to 12 during Self-administration Period 1.
|
Period 2: RLZ SRD
n=26 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with SRD once every week from Week 13 to 18 during Self-administration Period 2.
|
Period 2: RLZ MP
n=26 Participants
Randomized participants Self-administered RLZ dose subcutaneously as per their body weight with MP once every week from Week 13 to 18 during Self-administration Period 2.
|
RLZ Total
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Medication Errors Associated With Adverse Reactions During the 2 Self-administration Periods of the Study
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
Adverse Events
All Participants: Training Period
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Self-Administration Period 1 and 2: RLZ SRD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Self-Administration Period 1 and 2: RLZ MP
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
RLZ Total
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants: Training Period
n=62 participants at risk
All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization.
|
Self-Administration Period 1 and 2: RLZ SRD
n=54 participants at risk
Participants in Sequence 1 (from Week 7 to Week 12) and in Sequence 2 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the SRD administration method.
|
Self-Administration Period 1 and 2: RLZ MP
n=53 participants at risk
Participants in Sequence 2 (from Week 7 to Week 12) and in Sequence 1 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the MP administration method.
|
RLZ Total
n=62 participants at risk
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Myasthenia gravis
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/54 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/53 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
3.2%
2/62 • Number of events 2 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/54 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/53 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/54 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/53 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/54 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/53 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/54 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/53 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/54 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/53 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.6%
1/62 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
Other adverse events
| Measure |
All Participants: Training Period
n=62 participants at risk
All participants received weekly doses of subcutaneous rozanolixizumab (RLZ) as per their body weight. During the Training Period, the study participants were trained by healthcare professionals on the subcutaneous self-administration of RLZ using both the Syringe Driver (SRD) and Manual Push (MP) methods for 6 weeks before randomization.
|
Self-Administration Period 1 and 2: RLZ SRD
n=54 participants at risk
Participants in Sequence 1 (from Week 7 to Week 12) and in Sequence 2 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the SRD administration method.
|
Self-Administration Period 1 and 2: RLZ MP
n=53 participants at risk
Participants in Sequence 2 (from Week 7 to Week 12) and in Sequence 1 (from Week 13 to Week 18) received weekly doses of RLZ subcutaneously using the MP administration method.
|
RLZ Total
n=62 participants at risk
All study participants who received at least 1 dose of RLZ subcutaneously once every week with SRD or MP in Training Period, SA Period 1 and SA Period 2 for 18 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
4/62 • Number of events 4 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/54 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/53 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
8.1%
5/62 • Number of events 5 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
General disorders
Pyrexia
|
6.5%
4/62 • Number of events 4 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/54 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
5.7%
3/53 • Number of events 5 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
9.7%
6/62 • Number of events 10 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Infections and infestations
COVID-19
|
6.5%
4/62 • Number of events 4 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
0.00%
0/54 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/53 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
11.3%
7/62 • Number of events 7 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Nervous system disorders
Headache
|
19.4%
12/62 • Number of events 21 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
7.4%
4/54 • Number of events 7 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
1.9%
1/53 • Number of events 1 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
21.0%
13/62 • Number of events 29 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/62 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
5.6%
3/54 • Number of events 3 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
3.8%
2/53 • Number of events 2 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
8.1%
5/62 • Number of events 6 • From Week 1 up to the End of Study Visit (Week 26)
TEAEs were reported for SS and RSS. The RLZ Total arm includes data for all 62 participants from the Training Period to the Safety Follow-Up Period including participants who discontinued during the Training Period or were not randomized but continued in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60