Primary Membranous NephropathyPhase 2AUTUMNNCT07157787
Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)
A Phase 2 study testing ALXN1920 in people with Primary Membranous Nephropathy, run by Alexion Pharmaceuticals, Inc. at 40 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- ALXN1920
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 40 sitesin 10 countries
- Study dates
- 19 Sep 2025to 9 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 20 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:
- 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.
- 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.
- Having two proteinuria measurements with each > 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
- eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
- All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
Who cannot join
- 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 < 20 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
Show all 11Show fewer
- History of intolerance or hypersensitivity to ACEi or ARB
- Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period.
- Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening.
- Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
40 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
40 sites in 10 countries
Argentina7 sites, 5 recruiting
- Recruiting
Research Site
Buenos Aires, 1425
- Recruiting
Research Site
CABA, C1425HFA
- Recruiting
Research Site
Ciudad de Buenos Aires, 1280
- Not yet recruiting
Research Site
La Plata, B1902COS
- Recruiting
Research Site
Rosario, 2000
- Withdrawn
Research Site
Santa Fe, S3000EOZ
- Withdrawn
Research Site
Santa Fe, S3000
United States5 sites, 5 recruiting
- Recruiting
Research Site
Houston, Texas, 77030
- Recruiting
Research Site
Loma Linda, California, 92354
- Recruiting
Research Site
Minneapolis, Minnesota, 55435
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Recruiting
Research Site
San Diego, California, 92123
Brazil4 sites, 4 recruiting
- Recruiting
Research Site
Recife, 50670-901
- Recruiting
Research Site
Salvador, 40301-155
- Recruiting
Research Site
São Paulo, 04038-002
- Recruiting
Research Site
São Paulo, 05403-000
China4 sites, 4 recruiting
- Recruiting
Research Site
Baotou, 014010
- Recruiting
Research Site
Beijing, 100034
- Recruiting
Research Site
Guangzhou, 510080
- Recruiting
Research Site
Shenzhen, 518036
Spain4 sites, 4 recruiting
- Recruiting
Research Site
Barcelona, 08025
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Seville, 41013
- Recruiting
Research Site
Toledo, 45007
United Kingdom4 sites, 4 recruiting
- Recruiting
Research Site
Cambridge, CB2 0QQ
- Recruiting
Research Site
Leicester, LE5 4PW
- Recruiting
Research Site
London, SE5 9RJ
- Recruiting
Research Site
Salford, M6 8HD
Australia3 sites, 2 recruiting
- Active, not recruiting
Research Site
Gosford, 2250
- Recruiting
Research Site
Parkville, 3050
- Recruiting
Research Site
Southport, 4222
France3 sites, 2 recruiting
- Withdrawn
Research Site
Créteil, 94010
- Recruiting
Research Site
Nice, 06000
- Recruiting
Research Site
Toulouse, 31059
Italy3 sites, 3 recruiting
- Recruiting
Research Site
Milan, 20122
- Recruiting
Research Site
Ranica, 24020
- Recruiting
Research Site
Torrette, 60126
Taiwan3 sites, 3 recruiting
- Recruiting
Research Site
Kaohsiung City, 81362
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taoyuan, 333
About this study
Official 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
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- ALXN1920, Placebo
- Keywords
- Primary Membranous Nephropathy, PMN, ALXN1920
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1920Drug
Participants will receive ALXN1920 SC infusion.
PlaceboDrug
Participants will receive Placebo SC infusion.
| Study group | Role | What they receive |
|---|---|---|
| ALXN1920 | Experimental | Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab. Receives: Drug: ALXN1920 |
| Placebo | Experimental | Participants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
Measured: Baseline, Week 26
Secondary outcomes (6)
Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12
Measured: Baseline and week 12
Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26
Measured: Baseline, Week 12 and Week 26
Change From Baseline in Serum Albumin at Week 12 and week 26
Measured: Baseline, week 12 and Week 26
Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26
Measured: Baseline, week 12 and week 26
Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26
Measured: Baseline, Weeks 4, 8, 12 and 26
Change From Baseline biomarker level at Week 12 and 26
Measured: Baseline and Weeks 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start19 Sep 2025
- Primary completion2 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157787
- Sponsor's protocol ID
- D9900C00002
- Other IDs
- ALXN1920-PMN-201, 2025-520780-40, 2025
- Acronym
- AUTUMN
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07157787
- Acronym / sponsor ID
- AUTUMN / D9900C00002
- Conditions
- Primary Membranous Nephropathy
- Keywords
- Primary Membranous Nephropathy, PMN, ALXN1920
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALXN1920 | Experimental | Drug: ALXN1920Participants will receive ALXN1920 subcutaneous (SC) and background treatment of ACE/ARB and Rituximab. |
| Placebo | Experimental | Drug: PlaceboParticipants will receive placebo subcutaneous (SC) and background treatment of ACE/ARB and Rituximab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (> 20 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:
- eGFR60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula
- All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis
Key exclusion criteria (11 listed)
- 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 < 20 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALXN1920Participants will receive ALXN1920 SC infusion. | Drug | ALXN1920 |
| PlaceboParticipants will receive Placebo SC infusion. | Drug | Placebo |
Primary outcome
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26
Time frame: Baseline, Week 26
6 secondary outcomes
Change From Baseline in Proteinuria Based on 24-hour UPCR at week 12
Time frame: Baseline and week 12
Change From Baseline in Proteinuria Based on Spot UPCR at Week 12 and week 26
Time frame: Baseline, Week 12 and Week 26
Change From Baseline in Serum Albumin at Week 12 and week 26
Time frame: Baseline, week 12 and Week 26
Change From Baseline in Anti-phospholipase A2 Receptor (anti-PLA2R) Antibody Level at Week 12 and week 26
Time frame: Baseline, week 12 and week 26
Change From Baseline in Peripheral CD19+ B Cell Count at Week 4, Week 8, Week 12 and Week 26
Time frame: Baseline, Weeks 4, 8, 12 and 26
Change From Baseline biomarker level at Week 12 and 26
Time frame: Baseline and Weeks 12 and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALXN1920 in people with Primary Membranous Nephropathy, run by Alexion Pharmaceuticals, Inc. at 40 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Argentina, United States, Brazil, China, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Proteinuria Based on 24-hour UPCR at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.