Study of ALXN2050 in Proliferative Lupus Nephritis (LN) o... | NCT05097989 | Trialant
NCT05097989
Sponsor
Alexion Pharmaceuticals, Inc.
Status
Terminated
Last Update Posted
Oct 15, 2025Actual
Enrollment
100Actual
Phase
Phase 2
Conditions
Lupus Nephritis
Immunoglobulin A Nephropathy
IgAN
LN
Interventions
ALXN2050
Placebo
Countries
United States
Argentina
Australia
Brazil
China
Germany
Israel
Italy
Mexico
Serbia
South Korea
Spain
Taiwan
Thailand
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT05097989
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ALXN2050-NEPH-201
Secondary IDs
ID
Type
Description
Link
2021-001426-22
EudraCT Number
Brief Title
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Acronym
Not provided
Organization
Alexion Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor Decision.
Expanded Access Info
No
Start Date
Jan 14, 2022Actual
Primary Completion Date
Dec 9, 2024Actual
Completion Date
Dec 9, 2024Actual
First Submitted Date
Oct 18, 2021
First Submission Date that Met QC Criteria
Oct 18, 2021
First Posted Date
Oct 28, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 15, 2025
Results First Submitted that Met QC Criteria
Sep 25, 2025
Results First Posted Date
Oct 15, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 25, 2025
Last Update Posted Date
Oct 15, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alexion Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years.
Safety will be monitored throughout the study.
Detailed Description
Not provided
Conditions Module
Conditions
Lupus Nephritis
Immunoglobulin A Nephropathy
IgAN
LN
Keywords
ALXN2050
Complement Factor D
Complement Alternative Pathway
LN
IgAN
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
100Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LN Cohort: ALXN2050 180 mg
Experimental
Participants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
Drug: ALXN2050
LN Cohort: ALXN2050 120 mg
Experimental
Participants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
Drug: ALXN2050
LN Cohort: Placebo
Placebo Comparator
Participants diagnosed with LN with an active flare will receive matched placebo in addition to standard-of-care background therapy.
Drug: Placebo
IgAN Cohort: ALXN2050 180 mg
Experimental
Participants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
Drug: ALXN2050
IgAN Cohort: ALXN2050 120 mg
Experimental
Participants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
Drug: ALXN2050
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ALXN2050
Drug
Oral tablets
IgAN Cohort: ALXN2050 120 mg
IgAN Cohort: ALXN2050 180 mg
LN Cohort: ALXN2050 120 mg
LN Cohort: ALXN2050 180 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Baseline, Week 26
Secondary Outcomes
Measure
Description
Time Frame
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Baseline, Week 50
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Both Cohorts
Participants on sodium-glucose cotransporter-2 (SGLT 2) inhibitors (eg, empagliflozin) must be on a stable dose for ≥ 3 months with no planned change in dose during the Blinded Treatment Periods (through Week 50).
LN Cohort
Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria.
Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible.
Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator.
Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period.
IgAN Cohort
Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period.
Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period.
For participants with a kidney biopsy performed > 1 year prior to Screening that was used for eligibility: Presence of hematuria as defined by a positive result for blood on urine dipstick or ≥ 10 red blood cells (RBCs)/high power field (hpf) microscopy on urine sediment (documented by the local laboratory) during Screening Period. Presence of hematuria documented by the central laboratory may also be acceptable.
Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the Blinded Treatment Periods (through Week 50) (participants with established intolerance to RAS inhibitors may be included).
Controlled and stable blood pressure (defined as < 140/90 millimeters of mercury [mmHg]) over the past 3 months prior to randomization.
Key Exclusion Criteria:
Both Cohorts
eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration.
For participants with eGFR < 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior to or during the Screening
Period:
≥ 50% interstitial fibrosis and tubular atrophy
≥ 50% glomerular sclerosis
≥ 50% active crescent formation
Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period.
History of solid organ or bone marrow transplant, or planned transplant during the Blinded Extended Treatment Period (50 weeks).
Splenectomy or functional asplenia.
Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN).
Bone marrow insufficiency with absolute neutrophil count < 1.3 × 10^3/microliter; thrombocytopenia (platelet count < 50,000/cubic millimeter).
LN Cohort
Participants who have initiated any of the following treatments for the current active LN flare:
Cyclophosphamide ≤ 6 months prior to Screening
CNIs ≤ 1 months prior to Screening
A cumulative dose of intravenous (IV) methylprednisolone > 3 g
Mycophenolate mofetil > 2 g/day (or equivalent) for ≥ 8 consecutive weeks prior to Screening
Prednisone or prednisone equivalent ≥ 0.5 mg/kg/day for ≥ 8 consecutive weeks prior to Screening
Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg) on 2 or more measurements during the Screening Period.
Prior history or clinically active SLE-related cerebritis, seizures, stroke, or stroke syndrome requiring treatment or clinically active pericarditis
Inability to take or tolerate the standard of care background therapies
IgAN Cohort
Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period.
Secondary etiologies of IgAN.
Prednisone or prednisone equivalent > 20 mg/day for > 14 consecutive days or any other systemic immunosuppression for the treatment of IgAN ≤ 6 months prior to Screening
Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures > 30 minutes apart.
Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
For the immunoglobulin A nephropathy (IgAN) cohort, a total of 61 participants were enrolled in the study and randomized. For the lupus nephritis (LN) cohort, a total of 39 participants were enrolled in the study and randomized. Two doses of ALXN2050 were administered, 120 milligrams (mg) or 180 mg, both twice daily (bid).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
FG001
IgAN Cohort: ALXN2050 180 mg
Periods
Title
Milestones
Reasons Not Completed
Initial Evaluation Period (26 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 21, 2024
Aug 15, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Peru
Russia
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
Masking of treatment allocation will be observed at least until Week 50.
Participants diagnosed with IgAN will receive matched placebo in addition to standard-of-care background therapy.
Drug: Placebo
ACH-0145228 (formerly)
Placebo
Drug
Oral tablets
IgAN Cohort: Placebo
LN Cohort: Placebo
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms.
Week 26 and Week 50
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms.
Baseline, Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate >60 mL/min/1.73 m^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response.
Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate >60 mL/min/1.73 m^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Week 26 and Week 50
LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample
UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis.
Up to Week 50
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.
Week 12, Week 26, And Week 50
LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50
Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine >25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention.
Baseline Through Week 50
LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50
Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity.
Baseline Through Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50
Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Baseline through Week 50
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
For the determination of serum albumin, blood samples were obtained at designated time points. Results reported as grams/liter (g/L).
Baseline, Week 26 and Week 50
LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50
A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory.
Baseline Through Week 50
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50
Partial remission was defined as mean proteinuria <1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit.
Week 26 and Week 50
Loma Linda
California
92350
United States
Research Site
Northridge
California
91324
United States
Research Site
Gainesville
Florida
32603
United States
Research Site
Nampa
Idaho
83687
United States
Research Site
Des Moines
Iowa
50309
United States
Research Site
Kansas City
Missouri
64111
United States
Research Site
Albuquerque
New Mexico
87106
United States
Research Site
New York
New York
10016
United States
Research Site
Houston
Texas
77054
United States
Research Site
Ciudad de Buenos Aires
C1015ABO
Argentina
Research Site
Córdoba
5000
Argentina
Research Site
La Plata
B1902COS
Argentina
Research Site
Rosario
S2000DEJ
Argentina
Research Site
Clayton
3168
Australia
Research Site
Liverpool
2170
Australia
Research Site
Nedlands
6009
Australia
Research Site
Westmead
2145
Australia
Research Site
Belo Horizonte
30150-221
Brazil
Research Site
Curitiba
80030-110
Brazil
Research Site
Juiz de Fora
36010-570
Brazil
Research Site
Porto Alegre
90035-003
Brazil
Research Site
Porto Alegre
90480-000
Brazil
Research Site
Salvador
40150-150
Brazil
Research Site
Guangzhou
510080
China
Research Site
McKinney
75069
China
Research Site
Shanghai
200040
China
Research Site
Berlin
10117
Germany
Research Site
Essen
45122
Germany
Research Site
Mainz A. Rhein
55131
Germany
Research Site
Mannheim
68135
Germany
Research Site
Marburg
30625
Germany
Research Site
München
81377, DE
Germany
Research Site
Ashkelon
78306
Israel
Research Site
Haifa
3109601
Israel
Research Site
Petah Tikva
4941492
Israel
Research Site
Ramat Gan
52621
Israel
Research Site
Bari
70124
Italy
Research Site
Brescia
25123
Italy
Research Site
Milan
20132
Italy
Research Site
Naples
80131
Italy
Research Site
Torino
10154
Italy
Research Site
Guadalajara
44140
Mexico
Research Site
México
11570
Mexico
Research Site
Torreón
27000
Mexico
Research Site
Niš
18000
Serbia
Research Site
Novi Sad
21000
Serbia
Research Site
Busan
49241
South Korea
Research Site
Goyang-si
10380
South Korea
Research Site
Seoul
03080
South Korea
Research Site
Barcelona
08025
Spain
Research Site
Barcelona
8003
Spain
Research Site
Córdoba
14004
Spain
Research Site
Girona
17007
Spain
Research Site
L'Hospitalet de Llobregat
08907
Spain
Research Site
Palma de Mallorca
07120
Spain
Research Site
Seville
41013
Spain
Research Site
Valencia
46026
Spain
Research Site
Kaohsiung City
833
Taiwan
Research Site
New Taipei City
220
Taiwan
Research Site
New Taipei City
23561
Taiwan
Research Site
Taichung
40705
Taiwan
Research Site
Bangkok
10400
Thailand
Research Site
Istanbul
34093
Turkey (Türkiye)
Research Site
Bristol
BS105NB
United Kingdom
Research Site
Cambridge
CB2 0QQ
United Kingdom
Research Site
Doncaster
DN2 5LT
United Kingdom
Research Site
Leicester
LE5 4PW
United Kingdom
Research Site
London
E1 1BB
United Kingdom
Research Site
London
SE5 9RS
United Kingdom
Research Site
Manchester
M13 9WL
United Kingdom
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
FG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
FG003
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
FG004
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
FG005
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
FG006
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
FG007
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
FG008
LN Cohort: Placebo to Standard-of-care Background Therapy
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
FG0009 subjects
FG00126 subjects
FG00226 subjectsAt randomization, participants assigned to this group were also assigned to their study treatment for the Extended Treatment Period (ALXN2050 120 mg bid or ALXN2050 180 mg bid) in a 1:1 allocation ratio.
FG0030 subjects
FG0040 subjects
FG0056 subjects
FG00617 subjects
FG00716 subjects
FG0080 subjects
Received at Least 1 Dose of Study Drug
FG0009 subjects
FG00126 subjects
FG00226 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
FG00617 subjects
FG00716 subjects
FG0080 subjects
COMPLETED
FG0009 subjects
FG00126 subjects
FG00224 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG00613 subjects
FG00711 subjects
FG0080 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0054 subjects
FG0064 subjects
FG0075 subjects
FG0080 subjects
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Extended Treatment Period (24 Weeks)
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG00126 subjects
FG0020 subjectsAfter receiving placebo during the Initial Evaluation Period, participants in this cohort received either ALXN2050 180 mg or ALXN2050 120 mg, per randomization.
FG00312 subjectsAfter receiving placebo during the Initial Evaluation Period, participants in this cohort received ALXN2050 120 mg, per randomization.
FG00411 subjectsAfter receiving placebo during the Initial Evaluation Period, participants in this cohort received ALXN2050 180 mg, per randomization. One participant discontinued the study prior to entering the Extended Treatment Period.
FG0052 subjects
FG00613 subjects
FG00710 subjectsOne participant discontinued the study prior to entering the Extended Treatment Period.
FG0080 subjects
Received at Least 1 Dose of Study Drug
FG0006 subjects
FG00119 subjects
FG0020 subjects
FG00310 subjects
COMPLETED
FG0005 subjects
FG00114 subjects
FG0020 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG00112 subjects
FG0020 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Open-label Extension Period (2 Years)
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG00114 subjects
FG0020 subjects
FG0038 subjects
FG0046 subjects
FG0052 subjects
FG0065 subjectsOne participant discontinued the study prior to entering the Open-label Extension Period.
FG0070 subjectsAfter receiving placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period, participants in this cohort received standard-of-care background therapy only.
FG0086 subjectsAfter receiving placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period, participants in this cohort received standard-of-care background therapy only.
Received at Least 1 Dose of Study Drug
FG0004 subjects
FG00111 subjects
FG0020 subjects
FG0035 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG00114 subjects
FG0020 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
BG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
BG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
BG003
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
BG004
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
BG005
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG00126
BG00226
BG0036
BG00417
BG00516
BG006100
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
18 - 65 years
Title
Measurements
BG0009
BG00124
BG00225
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 26
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Mean
95% Confidence Interval
Percentage Change
Baseline, Week 26
ID
Title
Description
OG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
OG003
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG004
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG005
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0009
OG00125
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG000-29.3(-51.7 to 3.5)
OG001-26.2(-41.2 to -7.4)
OG002-10.3(-29.1 to 13.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
ANCOVA
0.2422
Percentage Difference
-17.7
2-Sided
90
-37.5
8.3
Other
OG004
OG005
ANCOVA
0.8701
Secondary
Both Cohorts: Percentage Change in Proteinuria From Baseline at Week 50
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A negative change from baseline indicated an improvement in symptoms.
Full Analysis Set: all participants who have been randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Mean
95% Confidence Interval
Percentage Change
Baseline, Week 50
ID
Title
Description
OG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
Secondary
Both Cohorts: Percentage of Participants Achieving >30% and >50% Reduction in Proteinuria at Week 26 and Week 50 Compared to Baseline
Proteinuria, the presence of excess proteins in the urine, was assessed using 24-hour urine collections obtained at designated timepoints. A reduction from baseline indicated an improvement in symptoms.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 26 and Week 50
ID
Title
Description
OG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
Secondary
Both Cohorts: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 and Week 50
Changes in kidney function were monitored using measurements of eGFR and calculated based on the Chronic Kidney Disease Epidemiology Collaboration formula. Results are reported in milliliters/minute/1.73 meters squared (mL/min/1.73 m^2). Estimates of change from baseline are least-square means based on a mixed-effect model for repeated measures model that included change from baseline as the response variable, treatment as independent variable and adjusts for covariates of baseline and the stratification factor at randomization. An increase in eGFR in response to treatment indicated an improvement in symptoms.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Least Squares Mean
Standard Error
mL/min/1.73 m^2
Baseline, Week 26 and Week 50
ID
Title
Description
OG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Complete Renal Response at Week 26 and Week 50
Complete renal response was defined as a decrease in urine protein to creatinine ratio (UPCR) to ≤0.5 gram/gram (g/g), an eGFR rate >60 mL/min/1.73 m^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal systemic lupus erythematosus (SLE) flare, or suboptimal response.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 26 and Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Partial Renal Response at Week 26 and Week 50
Partial renal response was defined as a decrease in UPCR ≥50% compared to baseline, an eGFR rate >60 mL/min/1.73 m^2 or no eGFR reduction ≥20% from baseline, and no treatment failure. Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 26 and Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Secondary
LN Cohort: Time to the First Occurrence of UPCR ≤0.5 g/g as Measured by a Spot Urine Sample
UPCR was assessed using 24-hour urine collections obtained at designated time points. The time to the first occurrence of UPCR ≤0.5 g/g was summarized by spot urine sample analysis.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Posted
Median
95% Confidence Interval
Weeks
Up to Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Secondary
LN Cohort: Percentage of Participants Achieving Corticosteroid Taper to 7.5 mg/Day at Weeks 12, 26, and 50
A corticosteroid taper was carried out per protocol at the clinical discretion of the investigator.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 12, Week 26, And Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Secondary
LN Cohort: Percentage of Participants Experiencing a Renal Flare Through Week 50
Renal flare was determined in the opinion of the investigator and additional protocol-specified criteria. For participants who achieved a complete renal response, a renal flare was the reproducible recurrence of proteinuria ≥1g/g. For all other participants, a renal flare was either of the following: a reproducible increase of serum creatinine >25% higher than baseline or above the upper limit of normal (plus additional protocol-specified criteria) or a reproducible doubling of the UPCR from a 24-hour urine collection compared with the lowest previous value obtained after the first dose of study intervention.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline Through Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Secondary
LN Cohort: Percentage of Participants Experiencing an Extrarenal SLE Flare Through Week 50
Extrarenal SLE flare was defined as an increase in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Safety of Estrogens in Lupus Erythematosus National Assessment modification ≥4 points that was not accounted for by proteinuria, hematuria, urinary cellular casts, hypocomplementemia, or an increase in anti-double-stranded DNA antibody level. The SLEDAI-2K is an instrument that was used to assesses the disease activity of extrarenal SLE flare across 18 disease descriptors. Each descriptor carried a weighted value ranging from 1-8, with the reported score calculated as the sum of these descriptors and ranging from 0 to 85. Higher scores represent increased degrees of disease activity.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline Through Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Treatment Failure Through Week 50
Treatment failure was defined as the receipt of additional standard of care therapy at any time during the study for protocol-defined renal flare, severe extrarenal SLE flare, or suboptimal response.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline through Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Secondary
LN Cohort: Change From Baseline in Serum Albumin at Week 26 and Week 50
For the determination of serum albumin, blood samples were obtained at designated time points. Results reported as grams/liter (g/L).
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure, and 'Number Analyzed' signifies those participants evaluable at the specified timepoints.
Posted
Mean
Standard Deviation
g/L
Baseline, Week 26 and Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Secondary
LN Cohort: Percentage of Participants Meeting the Criteria for Suboptimal Response Through Week 50
A suboptimal response was to be determined in the opinion of the investigator in addition to the following criterion: reproducible proteinuria ≤25% decreased compared to baseline based on UPCR on a 24-hour urine collection performed by a central laboratory.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Baseline Through Week 50
ID
Title
Description
OG000
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Secondary
IgAN Cohort: Percentage of Participants Meeting the Criteria for Partial Remission at Week 26 And Week 50
Partial remission was defined as mean proteinuria <1 g/24 hours, based on two valid 24-hour urine collections obtained within 2 weeks prior to the study visit.
Full Analysis Set: all participants who were randomized and received at least 1 dose of study intervention. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified timepoints.
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 26 and Week 50
ID
Title
Description
OG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
Time Frame
From baseline (Day 1) to end of the study (Day 813)
Description
Reported serious adverse events and other adverse events data based upon the Safety Set: all participants who received at least 1 dose of study intervention. Reported all-cause mortality data based upon the Randomized Set: all randomized participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IgAN Cohort: ALXN2050 120 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
0
9
0
9
7
9
EG001
IgAN Cohort: ALXN2050 180 mg
Participants diagnosed with IgAN received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
0
26
2
26
17
26
EG002
IgAN Cohort: Placebo
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period.
0
26
2
26
19
26
EG003
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
0
13
1
10
4
10
EG004
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
0
13
1
9
7
9
EG005
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
0
6
1
6
5
6
EG006
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
1
17
5
17
13
17
EG007
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
1
16
2
16
13
16
EG008
LN Cohort: Placebo to Standard-of-care Background Therapy
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period. The participants then received standard-of-care background therapy only during the Open-label Extension Period.
0
6
0
6
1
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected6 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Acute myelomonocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Renal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Skin candida
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Lupus nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Agranulocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected9 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected17 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected6 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0023 events3 affected26 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0023 events2 affected26 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Vaccination site pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0014 events4 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Ear infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Furuncle
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0013 events3 affected26 at risk
EG0024 events2 affected26 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Otitis media
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Otitis media bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Tonsillitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0023 events3 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0012 events2 affected26 at risk
EG0023 events2 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Ligament injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected9 at risk
EG0014 events4 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
High density lipoprotein increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Lipids abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0013 events3 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Exertional rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Tendon calcification
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Nervous system disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0015 events5 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Dizziness
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Headache
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0015 events5 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hypoaesthesia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Migraine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Paraesthesia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Peripheral sensory neuropathy
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Seizure
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Somnolence
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0022 events2 affected26 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0023 events3 affected26 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected10 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected10 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Diet noncompliance
Social circumstances
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Cataract
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
The study intervention dosing and recruitment were paused, consistent with a data monitoring committee recommendation. Given the anticipated length of the dosing interruption that would have impacted data interpretation following dosing re-initiation, the sponsor decided to terminate the study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D008180
Lupus Erythematosus, Systemic
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D020742
rhoA GTP-Binding Protein
Ancestor Terms
ID
Term
D020741
rho GTP-Binding Proteins
D020559
Monomeric GTP-Binding Proteins
D019204
GTP-Binding Proteins
D020558
GTP Phosphohydrolases
D017766
Acid Anhydride Hydrolases
D006867
Hydrolases
D004798
Enzymes
D045762
Enzymes and Coenzymes
D002352
Carrier Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D047908
Intracellular Signaling Peptides and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG004
9 subjects
FG0052 subjects
FG0069 subjects
FG00710 subjects
FG0080 subjects
6 subjects
FG0052 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjects
5 subjects
FG0050 subjects
FG0067 subjects
FG0074 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Study Terminated by Sponsor
FG0004 subjects
FG0018 subjects
FG0020 subjects
FG0031 subjects
FG0043 subjects
FG0050 subjects
FG0067 subjects
FG0073 subjects
FG0080 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG004
4 subjects
FG0051 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
6 subjects
FG0052 subjects
FG0065 subjects
FG0070 subjects
FG0086 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Study Terminated by Sponsor
FG0004 subjects
FG00112 subjects
FG0020 subjects
FG0038 subjects
FG0045 subjects
FG0052 subjects
FG0065 subjects
FG0070 subjects
FG0086 subjects
6
BG00417
BG00516
BG00697
>65 years
Title
Measurements
BG0000
BG0012
BG0021
BG0030
BG0040
BG0050
BG0063
10
BG0036
BG00412
BG00513
BG00653
Male
BG0006
BG00117
BG00216
BG0030
BG0045
BG0053
BG00647
5
BG0032
BG0049
BG0057
BG00634
Not Hispanic or Latino
BG0004
BG00120
BG00221
BG0034
BG0048
BG0059
BG00666
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0030
BG0042
BG0050
BG0062
Asian
BG0002
BG0015
BG0025
BG0033
BG0043
BG0054
BG00622
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Black or African American
BG0000
BG0011
BG0021
BG0030
BG0040
BG0051
BG0063
White
BG0007
BG00120
BG00220
BG0033
BG0049
BG0056
BG00665
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0043
BG0055
BG0068
2
OG00411
OG00511
-84.0
(-95.4 to -44.1)
OG004-58.0(-75.1 to -29.2)
OG005-55.4(-73.3 to -25.5)
Percentage Difference
-6.0
2-Sided
90
-49.3
74.4
Other
OG003
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG004
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG005
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG006
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0005
OG00112
OG0028
OG0036
OG0041
OG0055
OG0066
Title
Denominators
Categories
Title
Measurements
OG000-22.0(-58.9 to 48.0)
OG001-30.2(-53.6 to 4.9)
OG002-45.9(-67.5 to -9.9)
OG003-14.0(-52.2 to 54.6)
OG004-80.7(-95.6 to -16.5)
OG005-68.6(-83.5 to -40.4)
OG006-74.4(-85.9 to -53.5)
OG003
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG004
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG005
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG006
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG007
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0009
OG00126
OG00225
OG0039
OG0049
OG0054
OG00614
OG00711
Title
Denominators
Categories
Week 26: >30% Reduction
ParticipantsOG0009
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG00614
ParticipantsOG00711
Title
Measurements
OG00055.6(21.2 to 86.3)
OG00134.6(17.2 to 55.7)
OG00216.0(4.5 to 36.1)
OG005
Week 26: >50% Reduction
ParticipantsOG0009
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG0030
Week 50: >30% Reduction
ParticipantsOG0005
ParticipantsOG00114
ParticipantsOG0020
ParticipantsOG0039
Week 50: >50% Reduction
ParticipantsOG0005
ParticipantsOG00114
ParticipantsOG0020
ParticipantsOG0039
OG002
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG003
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG004
LN Cohort: ALXN2050 120 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG005
LN Cohort: ALXN2050 180 mg
Participants diagnosed with LN with an active flare received ALXN2050 in addition to standard-of-care background therapy throughout the entire study.
OG006
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0009
OG00125
OG00212
OG00311
OG0042
OG00511
OG00611
Title
Denominators
Categories
Week 26
ParticipantsOG0009
ParticipantsOG00125
ParticipantsOG00212
ParticipantsOG00311
ParticipantsOG0042
ParticipantsOG00511
ParticipantsOG00611
Title
Measurements
OG000-2.29± 2.625
OG001-0.47± 1.564
OG002-1.62± 2.248
OG003
Week 50
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG0028
ParticipantsOG0036
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0004
OG00114
OG00211
Title
Denominators
Categories
Week 26
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
OG00025.0(0.6 to 80.6)
OG00114.3(1.8 to 42.8)
OG0029.1(0.2 to 41.3)
Week 50
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0004
OG00114
OG00211
Title
Denominators
Categories
Week 26
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00211
Title
Measurements
OG00025.0(0.6 to 80.6)
OG00114.3(1.8 to 42.8)
OG00245.5(16.7 to 76.6)
Week 50
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0027
Title
Measurements
OG000
Units
Counts
Participants
OG0006
OG00117
OG00216
Title
Denominators
Categories
Title
Measurements
OG0002.4(2.1 to NA)Values were non-estimable (insufficient number of participants with events).
OG001NA(NA to NA)Values were non-estimable (insufficient number of participants with events).
OG00212.1(4.6 to NA)Values were non-estimable (insufficient number of participants with events).
Units
Counts
Participants
OG0003
OG00115
OG00214
Title
Denominators
Categories
Week 12
ParticipantsOG0003
ParticipantsOG00115
ParticipantsOG00214
Title
Measurements
OG000100(29.2 to 100)
OG001100(78.2 to 100)
OG00278.6(49.2 to 95.3)
Week 26
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG00211
Title
Measurements
OG000
Week 50
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0026
Title
Measurements
OG000
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0006
OG00117
OG00216
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.9(0.1 to 28.7)
OG0026.3(0.2 to 30.2)
OG002
LN Cohort: Placebo
Participants diagnosed with LN with an active flare received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period and the Extended Treatment Period.
Units
Counts
Participants
OG0006
OG00117
OG00216
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00218.8(4.0 to 45.6)
Units
Counts
Participants
OG0006
OG00117
OG00216
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.9(0.1 to 28.7)
OG00212.5(1.6 to 38.3)
Units
Counts
Participants
OG0002
OG00113
OG00211
Title
Denominators
Categories
Week 26
ParticipantsOG0001
ParticipantsOG00113
ParticipantsOG00211
Title
Measurements
OG00011.0
OG0011.5± 5.98
OG0024.1± 5.70
Week 50
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0026
Title
Measurements
OG000
Units
Counts
Participants
OG0006
OG00117
OG00216
Title
Denominators
Categories
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00135.3(14.2 to 61.7)
OG00218.8(4.0 to 45.6)
OG003
IgAN Cohort: Placebo to ALXN2050 120 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.
OG004
IgAN Cohort: Placebo to ALXN2050 180 mg
Participants diagnosed with IgAN received matched placebo in addition to standard-of-care background therapy during the Initial Evaluation Period. Participants then received ALXN2050 in addition to standard-of-care background therapy during the Extended Treatment Period and the Open-label Extension Period.