Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07157787




Registration number
NCT07157787
Ethics application status
Date submitted
28/08/2025
Date registered
5/09/2025
Date last updated
11/09/2025

Titles & IDs
Public title
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
Scientific title
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression
Secondary ID [1] 0 0
ALXN1920-PMN-201
Secondary ID [2] 0 0
D9900C00002
Universal Trial Number (UTN)
Trial acronym
AUTUMN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Membranous Nephropathy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALXN1920
Treatment: Drugs - Placebo

Experimental: ALXN1920 - Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.

Experimental: Placebo - Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab.


Treatment: Drugs: ALXN1920
Participants will receive ALXN1920 SC infusion.

Treatment: Drugs: Placebo
Participants will receive Placebo SC infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
Change From Baseline in Proteinuria Based on 24-hour UPCR
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Change From Baseline in Proteinuria Based on Spot UPCR at Week 26
Timepoint [2] 0 0
Baseline and Week 26
Secondary outcome [3] 0 0
Change From Baseline in Serum Albumin at Week 26
Timepoint [3] 0 0
Baseline and Week 26
Secondary outcome [4] 0 0
Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 26
Timepoint [4] 0 0
Baseline and 26
Secondary outcome [5] 0 0
Change From Baseline in Peripheral Cluster of Differentiation 20 (CD20+) B Cell Count at Week 4, Week 8, and Week 26
Timepoint [5] 0 0
Baseline, Weeks 4, 8 and 26
Secondary outcome [6] 0 0
Change From Baseline biomarker level at Week 26
Timepoint [6] 0 0
Baseline and Week 26

Eligibility
Key inclusion criteria
* Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 50 RU/mL) at Screening, which must be confirmed by a central laboratory
* Participants are willing to receive the background Standard of Care (SoC)
* Participants at high risk for disease progression, defined as:

1. Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.
2. Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure < 140 mmHg in = 75% of the readings within last 8 weeks.
3. Having two proteinuria measurements with each > 3.5 g/day, the second measurement showing =50% decrease from the first measurement.
* All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m^2 during Screening
* Documented rapid deterioration of kidney function
* History of life-threatening Nephrotic Syndrome within 1 year before Screening
* Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R < 50 RU/mL or kidney disease other than PMN
* History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period
* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period
* History or presence of any clinically relevant co-morbidities
* History of intolerance or hypersensitivity to ACEi or ARB
* Use of SGLT2i, MRA, or ERA within 8 weeks prior to randomization and throughout the study period

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/03/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment hospital [3] 0 0
Research Site - Southport
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Argentina
State/province [4] 0 0
Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
CABA
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciudad de Buenos Aires
Country [7] 0 0
Argentina
State/province [7] 0 0
Rosario
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Brazil
State/province [9] 0 0
Recife
Country [10] 0 0
Brazil
State/province [10] 0 0
Salvador
Country [11] 0 0
Brazil
State/province [11] 0 0
São Paulo
Country [12] 0 0
China
State/province [12] 0 0
Baotou
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Guangzhou
Country [15] 0 0
China
State/province [15] 0 0
Shenzhen
Country [16] 0 0
France
State/province [16] 0 0
Créteil
Country [17] 0 0
France
State/province [17] 0 0
Nice
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
Italy
State/province [19] 0 0
Milan
Country [20] 0 0
Italy
State/province [20] 0 0
Ranica
Country [21] 0 0
Italy
State/province [21] 0 0
Torrette
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Seville
Country [25] 0 0
Spain
State/province [25] 0 0
Toledo
Country [26] 0 0
Taiwan
State/province [26] 0 0
Kaohsiung City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taichung
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taoyuan District
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Cambridge
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Leicester
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc. (Sponsor)
Address 0 0
Country 0 0
Phone 0 0
1-855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07157787