Clinical trial NCT05398653: A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy
Official title: A Multicenter, Randomized, Controlled, Open Phase Ib/ Ⅱ Study Evaluating the Efficacy and Safety of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Primary Membranous Nephropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Membranous Nephropathy
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in each group. Tolerance to MIL62 was evaluated within 4 weeks after the first administration. If the overall safety is determined by the investigator and sponsor to be tolerable to MIL62, phase II enrollment will be initiated.

The second stage was also randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups according to the ratio of 1:1:1, 30 subjects in each group, to evaluate the efficacy of MIL62 and cyclosporine in the treatment of primary membranous nephropathy. Eligible subjects in both phases received treatment and follow-up for a total of 104 weeks. The 76-week overall response rate was the primary endpoint.


Eligibility criteria: Inclusion Criteria:

1. Adult patients, ≥18 years of age;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
3. Best support for 3 months before the screening and above, 24 hours urinary protein 5 g or higher, or screening best support treatment before 6 months or more, 24 hours urinary protein \> 3.5 g, and urine protein decreased 50% or less, or if it always has the best support after a full course of treatment, 24 hours urinary protein is still more than standard after confirmed by the researchers can into the group;
4. eGFR ≥40 mL/min/1.73m\^2 or qualified endogenous creatinine clearance ≥40 mL/min/1.73m\^2 based on 24-hour urine collection during screening；
5. Sufficient organ function;
6. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Participants with a secondary cause of MN；
2. Cyclosporine resistance；
3. Urine protein decreased by \> 50% within 6 months before screening；
4. Received treatment drugs for membranous nephropathy；
5. Concomitant with other serious diseases；
6. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;Central nervous system metastasis；
7. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment；
9. Other exclusion criteria may apply；

Primary outcomes:
measure: Stage 1: Percentage of Participants with Adverse Events
timeFrame: up to 2year after enrollment
measure: Stage 2: Overall response rate (CR+PR) at Week 76
timeFrame: Week 76
Secondary outcomes:
measure: Stage 2: complete response, partial response, and overall response (CR+PR) at 104 weeks
timeFrame: Week 104
measure: Stage 2: Complete response rate, partial response rate and overall response rate at 24 weeks and 52 weeks (CR+PR)
timeFrame: Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: