Trial Outcomes & Findings for Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus (NCT NCT05306873)
NCT ID: NCT05306873
Last Updated: 2025-09-09
Results Overview
Treatment failure is defined as the first occurrence after randomization (Stage 2) of any of the following events: 1. Methylprednisolone acetate injection or treatment with a new or increased lupus medication, except the occasional use of corticosteroids for reasons not associated with Systemic Lupus Erythematosus (SLE) flare 2. British Isles Lupus Assessment Group (BILAG) flare, defined as any item marked new or worse that could support a BILAG A (severe flare) or 2 organs with items marked new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
From Baseline to Stage 2 Week 24
Results posted on
2025-09-09
Participant Flow
10 sites were activated in the United States, beginning in October 2022. In Stage 1, 12 consenting participants received an intramuscular injection of a long-acting corticosteroid injection and withdrew from all other treatments for lupus. In Stage 2, 8 eligible participants were randomized to receive either MMF or placebo. In Stage 3, 3 eligible participants from Stage 2 were re-randomized to receive either MMF + Voclosporin or MMF + Placebo.
A total of 12 participants consented from November 2022 to April 2024 at 7 sites.
Participant milestones
| Measure |
Stage 2 MMF
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
Stage 3 MMF + Voclosporin
Participants receive up to 24 weeks of MMF plus 23.7 mg voclosporin (3 x 7.9 mg capsules) twice daily. Participants who previously received placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who receive MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
Stage 3 MMF + Placebo for Voclosporin
Participants receive up to 24 weeks of MMF plus 23.7 mg voclosporin placebo (3 x 7.9 mg capsules) twice daily. Participants who previously received MMF placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who received MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
|---|---|---|---|---|
|
Stage 2
STARTED
|
4
|
4
|
0
|
0
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
4
|
4
|
0
|
0
|
|
Stage 3
STARTED
|
0
|
0
|
2
|
1
|
|
Stage 3
COMPLETED
|
0
|
0
|
1
|
0
|
|
Stage 3
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Stage 2 MMF
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
Stage 3 MMF + Voclosporin
Participants receive up to 24 weeks of MMF plus 23.7 mg voclosporin (3 x 7.9 mg capsules) twice daily. Participants who previously received placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who receive MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
Stage 3 MMF + Placebo for Voclosporin
Participants receive up to 24 weeks of MMF plus 23.7 mg voclosporin placebo (3 x 7.9 mg capsules) twice daily. Participants who previously received MMF placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who received MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
|---|---|---|---|---|
|
Stage 2
Study stopped
|
1
|
1
|
0
|
0
|
|
Stage 2
Stage 2 Treatment Failure
|
2
|
3
|
0
|
0
|
|
Stage 2
Logistical issues due to participant moving
|
1
|
0
|
0
|
0
|
|
Stage 3
Stage 3 Treatment Failure
|
0
|
0
|
0
|
1
|
|
Stage 3
Study Stopped
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
Baseline characteristics by cohort
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
Stage 3 MMF + Voclosporin
n=2 Participants
Participants receive up to 24 weeks of MMF plus 23.7 mg voclosporin (3 x 7.9 mg capsules) twice daily. Participants who previously received placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who receive MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
Stage 3 MMF + Placebo for Voclosporin
n=1 Participants
Participants receive up to 24 weeks of MMF plus 23.7 mg volvlosporin placebo (3 x 7.9 mg capsules) twice daily. Participants who previously received MMF placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.
Participants who received placebo in Stage 2:
* Week 1: participants receive 500 mg MMF plus matching placebo (to appear like a 1000mg dose) twice daily
* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses
* Weeks 3-24: 1000 mg MMF twice daily
Participants who received MMF in Stage 2:
• Weeks 1-24: 1000 mg MMF twice daily
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Stage 2
|
40.5 years
STANDARD_DEVIATION 15.89 • n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
42.5 years
STANDARD_DEVIATION 12.77 • n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
39.4 years
STANDARD_DEVIATION 11.16 • n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Age, Continuous
Stage 3
|
—
|
—
|
39.5 years
STANDARD_DEVIATION 13.44 • n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
53.0 years
STANDARD_DEVIATION NA • n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
44.0 years
STANDARD_DEVIATION 12.29 • n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Sex: Female, Male
Stage 2 · Female
|
4 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
4 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
8 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Sex: Female, Male
Stage 2 · Male
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Sex: Female, Male
Stage 3 · Female
|
—
|
—
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Sex: Female, Male
Stage 3 · Male
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Hispanic or Latino
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
1 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Not Hispanic or Latino
|
4 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
3 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
7 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 3 · Hispanic or Latino
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 3 · Not Hispanic or Latino
|
—
|
—
|
2 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
3 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Ethnicity (NIH/OMB)
Stage 3 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · American Indian or Alaska Native
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · Asian
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · Black or African American
|
1 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
2 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · White
|
3 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
2 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
5 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · More than one race
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
1 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 2 · Unknown or Not Reported
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
—
|
—
|
0 Participants
n=8 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · Asian
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · Black or African American
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · White
|
—
|
—
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
2 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · More than one race
|
—
|
—
|
1 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Race (NIH/OMB)
Stage 3 · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
0 Participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
4 participants
n=4 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
2 participants
n=2 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
1 participants
n=1 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
3 participants
n=3 Participants • Data are being reported separately for Stage 2 and Stage 3. The participants in Stage 3 are a subset of the participants in Stage 2.
|
PRIMARY outcome
Timeframe: From Baseline to Stage 2 Week 24Population: The modified Intent-to-Treat population includes all Stage 2 randomized participants who received at least one dose of Stage 2 study drug.
Treatment failure is defined as the first occurrence after randomization (Stage 2) of any of the following events: 1. Methylprednisolone acetate injection or treatment with a new or increased lupus medication, except the occasional use of corticosteroids for reasons not associated with Systemic Lupus Erythematosus (SLE) flare 2. British Isles Lupus Assessment Group (BILAG) flare, defined as any item marked new or worse that could support a BILAG A (severe flare) or 2 organs with items marked new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason
Outcome measures
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Stage 2 Week 24Population: Includes all Stage 2 randomized participants who received at least one dose of Stage 2 study drug and had evaluable data at the Stage 2 Week 24 visit. Participants who experience treatment failure prior to Stage 2 Week 24 visit are considered BICLA Non-responders at Stage 2 Week 24.
The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as meeting all of the following criteria: * Improvement of all Screening BILAG A scores to B, C or D * Improvement of all Screening BILAG B scores to C or D * No new BILAG A score among organs scored as B, C, D, or E at Screening * \<= 1 new BILAG B score among organs scored as C, D, or E at Screening * No worsening of the Hybrid Systemic Lupus Erythematosus Disease Activity Index (H-SLEDAI) * Less than a 10% increase (worsening) in the Physician's Global Assessment (PGA) Participants who experience treatment failure prior to Stage 2 Week 24 visit are imputed as BICLA Non-responders at Stage 2 Week 24. Participants who do not have evaluable data at Stage 2 Week 24 for reasons other than a treatment failure are not imputed.
Outcome measures
| Measure |
Stage 2 MMF
n=3 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=3 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24.
BICLA Responder
|
1 Participants
|
0 Participants
|
|
Clinical Response in Stage 2, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24.
BICLA Non-responder
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From re-randomization to Stage 3 Week 24Population: The Stage 3 modified Intent-to-Treat population consists of all Stage 3 re-randomized participants who received at least one dose of Stage 3 study drug.
Treatment failure is defined as the first occurrence after re-randomization (Stage 3) of any of the following events: 1. Methylprednisolone acetate injection or treatment with a new or increased lupus medication, except the occasional use of corticosteroids for reasons not associated with Systemic Lupus Erythematosus (SLE) flare 2. British Isles Lupus Assessment Group (BILAG) flare, defined as any item marked new or worse that could support a BILAG A (severe flare) or 2 organs with items marked new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason
Outcome measures
| Measure |
Stage 2 MMF
n=2 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Proportion of Participants Who Experience a Stage 3 Treatment Failure, After Stage 3 Re-randomization at or Before Completing Stage 3 Week 24.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of Stage 3 up to the day of treatment failurePopulation: All Stage 3 re-randomized participants who received at least one dose of Stage 3 study drug and experienced a Stage 3 treatment failure.
Treatment failure is defined as the first occurrence after re-randomization (Stage 3) of any of the following events: 1. Methylprednisolone acetate injection or treatment with a new or increased lupus medication, except the occasional use of corticosteroids for reasons not associated with Systemic Lupus Erythematosus (SLE) flare 2. British Isles Lupus Assessment Group (BILAG) flare, defined as any item marked new or worse that could support a BILAG A (severe flare) or 2 organs with items marked new or worse that could support a BILAG B (moderate flare), and if the participant's condition is deemed by the investigator to be "moderately worse" or "much worse" compared to the day of randomization, as assessed by the Clinician Global Impression of Change (CGI-C) 3. Premature permanent discontinuation of study-assigned treatment for any reason
Outcome measures
| Measure |
Stage 2 MMF
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
Time to Treatment Failure in Stage 3, Defined as the Interval From the Day of Stage 3 Randomization Until the Day of Treatment Failure.
|
—
|
69 Days
Standard Deviation NA
Standard deviation cannot be calculated since there is only one participant
|
SECONDARY outcome
Timeframe: Stage 3 Week 24Population: Includes all Stage 3 re-randomized participants who received at least one dose Stage 3 study drug and had evaluable data at the Stage 3 Week 24 visit. Participants who experience treatment failure prior to Stage 3 Week 24 visit are considered BICLA Non-responders at Stage 3 Week 24.
The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as meeting all of the following criteria: * Improvement of all Screening BILAG A scores to B, C or D * Improvement of all Screening BILAG B scores to C or D * No new BILAG A score among organs scored as B, C, D, or E at Screening * \<= 1 new BILAG B score among organs scored as C, D, or E at Screening * No worsening of the Hybrid Systemic Lupus Erythematosus Disease Activity Index (H-SLEDAI) * Less than a 10% increase (worsening) in the Physician's Global Assessment (PGA) Participants who experience treatment failure prior to Stage 3 Week 24 visit are imputed as BICLA Non-responders at Stage 2 Week 24. Participants who do not have evaluable data at Stage 3 Week 24 for reasons other than a treatment failure are not imputed.
Outcome measures
| Measure |
Stage 2 MMF
n=1 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
Clinical Response in Stage 3, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 3 Week 24.
BICLA Responder
|
0 Participants
|
0 Participants
|
|
Clinical Response in Stage 3, Defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 3 Week 24.
BICLA Non-responder
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Stage 2 Day 0 up to Stage 2 Week 48Population: Includes all participants who received at least one dose of Stage 2 study drug.
Defined as adverse events that emerged during Stage 2 that are of Grade 3 or higher with a relationship to Stage 2 study drug of Possible or Definite.
Outcome measures
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After Stage 3 re-randomization Day 0 to Stage 3 Week 24Population: Includes all participants who received at least one dose of Stage 3 study drug.
Defined as adverse events that emerged during Stage 3 that are of Grade 3 or higher with a relationship to Stage 3 study drug of Possible or Definite.
Outcome measures
| Measure |
Stage 2 MMF
n=2 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Related Adverse Events (AEs) in Stage 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -28 to Day -1Population: Includes all participants who receive at least one IM injection of a long-acting corticosteroid or who initiate withdrawal of lupus medications in Stage 1.
Defined as infection adverse events that emerged during Stage 1 and are of Grade 3 or higher.
Outcome measures
| Measure |
Stage 2 MMF
n=12 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Infections in Stage 1
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Stage 2 Day 0 up to Stage 2 Week 48Population: Includes participants who received at least one dose of Stage 2 study drug.
Defined as infection adverse events that emerged during Stage 2 and are of Grade 3 or higher.
Outcome measures
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Infections in Stage 2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: After Stage 3 re-randomization Day 0 to Stage 3 Week 24Population: Includes participants who received at least one dose of Stage 3 study drug.
Defined as infection adverse events that emerged during Stage 3 and are of Grade 3 or higher.
Outcome measures
| Measure |
Stage 2 MMF
n=2 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Infections in Stage 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -28 to Day -1Population: Includes all participants who receive at least one IM injection of a long-acting corticosteroid or who initiate withdrawal of lupus medications in Stage 1.
Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Outcome measures
| Measure |
Stage 2 MMF
n=12 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Renal Dysfunction in Stage 1
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Stage 2 Day 0 up to Stage 2 Week 48Population: Includes participants who received at least one dose of Stage 2 study drug.
Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Outcome measures
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Renal Dysfunction in Stage 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After Stage 3 re-randomization Day 0 to Stage 3 Week 24Population: Includes participants who received at least one dose Stage 3 study drug.
Defined as Grade 3 or higher chronic kidney disease with eGFR \< 30 ml/min per 1.73 m\^2
Outcome measures
| Measure |
Stage 2 MMF
n=2 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Renal Dysfunction in Stage 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -28 to Day -1Population: Includes all participants who receive at least one IM injection of a long-acting corticosteroid or who initiate withdrawal of lupus medications in Stage 1.
Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Outcome measures
| Measure |
Stage 2 MMF
n=12 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Hypertension in Stage 1
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Stage 2 Day 0 up to Stage 2 Week 48Population: Includes participants who received at least one dose of Stage 2 study drug.
Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Outcome measures
| Measure |
Stage 2 MMF
n=4 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=4 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Hypertension in Stage 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After Stage 3 re-randomization Day 0 to Stage 3 Week 24Population: Includes participants who received at least one dose Stage 3 study drug.
Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Outcome measures
| Measure |
Stage 2 MMF
n=2 Participants
Participants receive up to 48 weeks of MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of MMF twice a day for 7 days, followed by 500 mg and 1000 mg of MMF in divided doses for 7 days, followed by a continued stable dose of 1000 mg of MMF twice a day.
|
Stage 2 Placebo for MMF
n=1 Participants
Participants receive up to 48 weeks of placebo for MMF. A scheduled ramp-up takes place for the first two weeks. Participants receive 500 mg of placebo twice a day for 7 days, followed by 500 mg and 1000 mg of placebo in divided doses for 7 days, followed by a continued stable dose of 1000 mg of placebo twice a day.
|
|---|---|---|
|
The Incidence of Grade 3 or Higher Hypertension in Stage 3
|
0 Participants
|
0 Participants
|
Adverse Events
Stage 1 Corticosteroid During Treatment Withdrawal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 2 MMF
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 2 Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 3 MMF + Voclosporin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 3 MMF + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Corticosteroid During Treatment Withdrawal
n=12 participants at risk
Participants receive up to 3 corticosteroid injections to achieve amelioration of symptoms and withdraw from lupus treatments. Stage 1 may last up to 4 weeks.
|
Stage 2 MMF
n=4 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) for up to 48 weeks.
|
Stage 2 Placebo
n=4 participants at risk
Participants receive Placebo twice daily for up to 48 weeks.
|
Stage 3 MMF + Voclosporin
n=2 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) plus 23.7 mg of Voclosporin twice daily for up to 24 weeks.
|
Stage 3 MMF + Placebo
n=1 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) plus Placebo twice daily for up to 24 weeks.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
Other adverse events
| Measure |
Stage 1 Corticosteroid During Treatment Withdrawal
n=12 participants at risk
Participants receive up to 3 corticosteroid injections to achieve amelioration of symptoms and withdraw from lupus treatments. Stage 1 may last up to 4 weeks.
|
Stage 2 MMF
n=4 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) for up to 48 weeks.
|
Stage 2 Placebo
n=4 participants at risk
Participants receive Placebo twice daily for up to 48 weeks.
|
Stage 3 MMF + Voclosporin
n=2 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) plus 23.7 mg of Voclosporin twice daily for up to 24 weeks.
|
Stage 3 MMF + Placebo
n=1 participants at risk
Participants receive 1000 mg MMF twice daily (following a 2 week ramp up) plus Placebo twice daily for up to 24 weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Cardiac disorders
Pericarditis
|
8.3%
1/12 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Appendicitis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
50.0%
1/2 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
50.0%
1/2 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
50.0%
1/2 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
50.0%
1/2 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/12 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/4 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
25.0%
1/4 • Number of events 1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/2 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
0.00%
0/1 • AEs Grade 2+ or COVID-19 AEs Grade 1+ from consent until study completion, or until 30 days after early withdrawal (without withdrawing consent), or withdrawal from study, up to 56 weeks. Max time to complete Stage 2 is 4 weeks in Stage 1 + 48 weeks in Stage 2 + 4 weeks in Safety F/U = 56 weeks. For Stage 3, treatment failure occurs at or before Stage 2 Week 24 visit. Max time to complete Stage 3 is 4 weeks in Stage 1 + 24 weeks in Stage 2 + 24 weeks in Stage 3 +4 weeks in Safety F/U = 56 weeks.
AEs are reported in the stage in which the event emerged
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place