BridgeMD
Phase 2a Study of ALXN1920 in PMN
EU CTIS ID: 2025-520780-40-00
What this study is testing
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 UPCR
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be ≥18 and ≤75 years of age at the time of signing the informed consent.
- To reduce the risk of infections, all participants must receive prophylactic treatment with appropriate antibiotics while receiving RTX and be willing to be vaccinated against Neisseria meningitidis.
- Participants who have a documented diagnosis of PMN, established by positive anti PLA2R antibody level (≥ 20 RU/mL) at Screening, which must be confirmed by a central laboratory.
- Participants at high risk for disease progression, defined as: a. Receiving ACE inhibitors or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level; however, participants with less than 8 weeks on ACE or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period for up to 8 weeks, b. Participants who are on ACE inhibitors or ARB for a minimum of 8 weeks with SBP < 140 mmHg in ≥ 75% of the readings (within the last 8 weeks) are allowed to be randomized, and c. Having two proteinuria measurements by either a 24-hour urine collection or a spot urine with each > 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
- eGFR ≥ 60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula.
- Male or female assigned at birth, inclusive of all gender identities.
You likely can't join if
- History of malignancy within 5 years prior to Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Any previous or current treatment with complement inhibitors (including but not limited to, eculizumab, ravulizumab).
- Presence of hepatitis B surface antigen (HBsAg) and/or HBV DNA positive at Screening or documented within preceding 3 months. NOTE: a. Participants with known positive HBsAb may be randomized provided they are hepatitis B-vaccinated and have negative HBsAg and HBcAb. b. Participants with isolated anti-HBc positivity (total anti-HBc positive, HBsAg negative) may be randomized if they have negative HBV DNA during the Screening period. c. Participants with evidence of past resolved HBV infection (HBcAb/anti HBc positive and anti HBs positive) may be randomized if HBV DNA is negative; document past infection in Medical History).
- Anti-CD20 antibody use within 6 months prior to Screening.
- Participants who are receiving or have received obinutuzumab.
- Cyclophosphamide use within 6 months prior to Screening.
See the full eligibility criteria
Who can join
- Participant must be ≥18 and ≤75 years of age at the time of signing the informed consent.
- To reduce the risk of infections, all participants must receive prophylactic treatment with appropriate antibiotics while receiving RTX and be willing to be vaccinated against Neisseria meningitidis.
- Participants who have a documented diagnosis of PMN, established by positive anti PLA2R antibody level (≥ 20 RU/mL) at Screening, which must be confirmed by a central laboratory.
- Participants at high risk for disease progression, defined as: a. Receiving ACE inhibitors or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level; however, participants with less than 8 weeks on ACE or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period for up to 8 weeks, b. Participants who are on ACE inhibitors or ARB for a minimum of 8 weeks with SBP < 140 mmHg in ≥ 75% of the readings (within the last 8 weeks) are allowed to be randomized, and c. Having two proteinuria measurements by either a 24-hour urine collection or a spot urine with each > 3.5 g/day, the second measurement showing ≤50% decrease from the first measurement.
- eGFR ≥ 60 mL/min/1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula.
- Male or female assigned at birth, inclusive of all gender identities.
- Agree to follow protocol-specified contraception guidance.
- Signed informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative.
- Participants are willing to receive the background SoC.
What rules you out
- History of malignancy within 5 years prior to Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Any previous or current treatment with complement inhibitors (including but not limited to, eculizumab, ravulizumab).
- Presence of hepatitis B surface antigen (HBsAg) and/or HBV DNA positive at Screening or documented within preceding 3 months. NOTE: a. Participants with known positive HBsAb may be randomized provided they are hepatitis B-vaccinated and have negative HBsAg and HBcAb. b. Participants with isolated anti-HBc positivity (total anti-HBc positive, HBsAg negative) may be randomized if they have negative HBV DNA during the Screening period. c. Participants with evidence of past resolved HBV infection (HBcAb/anti HBc positive and anti HBs positive) may be randomized if HBV DNA is negative; document past infection in Medical History).
- Anti-CD20 antibody use within 6 months prior to Screening.
- Participants who are receiving or have received obinutuzumab.
- Cyclophosphamide use within 6 months prior to Screening.
- History of life-threatening Nephrotic Syndrome (serum albumin <2.5 g/dL AND either treatment refractory edema or thromboembolic event) within 1 year before Screening.
- Immunosuppressants other than anti-CD20 antibody or cyclophosphamide used within 12 weeks prior to Screening.
- Participants who are unable to take at least 1 antimicrobial agent used to prevent N meningitidis.
- Participation in another investigational drug or investigational device study within 30 days before initiation of study intervention on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
- Pregnant, breastfeeding, or intending to conceive during the course of the study.
- History of hypersensitivity to any ingredient contained in the study intervention, including inability to take or tolerate the allowed concomitant therapies.
- History of resistance to RTX defined as one of the following: • having a reduction in proteinuria of <25% after 6 months of treatment with RTX (including any increase in proteinuria), or, • reduction in anti-PLA2R antibody levels < 25% at 3 months, or < 50% at 6 months, after treatment with RTX Note: Participants who previously responded to RTX with either a CR or PR but relapsed at least 6 months after last RTX dose are eligible (relapse is defined as a return of proteinuria to > 3.5 g/day after an initial CR or PR to immunosuppressive therapy
- History of intolerance or hypersensitivity to ACEi or ARB, including but not limited to angioedema, persistent cough, or clinically significant hypotension attributed to these agents.
- Positive hepatitis C antibody test result at screening or within 3 months unless HCV RNA negative test is documented.
- Diagnosis of anti-PLA2R negative 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.
- Splenectomy or functional asplenia.
- Known or suspected complement deficiency, unless attributable to underlying disease.
- Positive COVID-19 test at Screening. NOTE: At Screening, SARS‑CoV‑2 status must be confirmed by PCR. Participants with a PCR‑positive result for SARS‑CoV‑2 will be excluded from the study. Rescreening will be permitted once symptoms have resolved and a repeat SARS‑CoV‑2 test is negative, in accordance with local guidelines.
- Participants with active or latent TB.
- Documented rapid deterioration of kidney function (20% or greater decline in eGFR sustained over a period of at least 3 months within 24 months before Screening)
- Hereditary (primary) hypogammaglobulinemia (as confirmed by medical history), including but not limited to X-linked agammaglobulinemia, CVID, or other diagnosed primary immunodeficiency disorders associated with significantly reduced immunoglobulin levels.
- Participants with history of HIV who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening.
- Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant’s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
- History of any Neisseria infection.
- History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to Day 1.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to first dose of study intervention.
- QTc > 480 msec in participants with bundle branch block.
- Traditional Chinese medicines and Chinese proprietary medicines with systemic immunosuppressive properties including but not limited to Tripterygium Wilfordii or Tripterygium Wilfordii-containing medicines for the treatment of PMN within 6 months prior to Screening.
- Participants with initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization are excluded. Furthermore, the Investigators should not plan any new initiation or dose adjustment of SGLT2i during the 26‑week Blinded Treatment Period.
- Use of MRA or ERA within 12 weeks prior to randomization and throughout the study period.
- Participants with BMI > 40.
- Uncontrolled HTN, defined as BP ≥ 140 mm Hg systolic and/or ≥ 90 mm Hg diastolic on ≥3 BP medications.
- Laboratory abnormalities at Screening, including: • ALT > 2 × ULN • Direct bilirubin > 2 × ULN • HbA1c at Screening > 6.5%
- Any other clinically significant laboratory abnormality that, in the opinion of the Investigator, would make the participant inappropriate for the study or put the participant at undue risk.
- A history of Diabetes Mellitus Type 1 and diagnosis of Diabetes Mellitus Type 2.
- Current treatment with a biologic medication that may affect immune system functioning or previous treatment with a biologic medication that may affect immune system functioning stopped within 30 days or 5 terminal half-lives of the biologic medication, whichever is longer, prior to Screening Visit.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- Taiwan
- Australia
- Argentina
- United Kingdom
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; Taiwan; Australia; Argentina; United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.