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Monoclonal Antibodies

MOR202 for Membranous Glomerulonephritis (M-PLACE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by HI-Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

M-PLACE Trial Summary

This trial will study the safety and effectiveness of an antibody drug in people with a kidney disease called membranous nephropathy.

Eligible Conditions
  • Membranous Glomerulonephritis
  • Membranous Nephropathy

M-PLACE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
safety and tolerability: incidence and severity of treatment-emergent adverse events
Secondary outcome measures
PK profile
effect of MOR202 on serum anti-PLA2R antibodies
immunogenicity of MOR202
+1 more

Side effects data

From 2020 Phase 1 & 2 trial • 91 Patients • NCT01421186
52%
Plasma cell myeloma
42%
Anaemia
35%
Fatigue
32%
Nausea
26%
Leukopenia
23%
Diarrhea
19%
Infusion related reaction
19%
Nasopharyngitis
19%
Headache
16%
Pyrexia
16%
Musculoskeletal chest pain
16%
Lymphopenia
16%
Hypokalaemia
13%
Plasma Cell Myeloma
13%
Constipation
13%
Neutropenia
13%
Dyspnoea
13%
Infusion-related reaction
13%
Bronchitis
13%
Vomiting
13%
Hypertension
10%
Hypophosphataemia
10%
Cough
10%
Night sweats
10%
Hyperhidrosis
10%
Bone pain
10%
Tachycardia
10%
Thrombocytopenia
10%
Blood lactate dehydrogenase increased
10%
Upper respiratory tract infection
10%
Oedema peripheral
10%
Muscle spasm
10%
Dizziness
10%
Hypotension
10%
Pain in extremity
6%
Nasal congestion
6%
Acute Kidney Injury
6%
Dyspnoea exertional
6%
Rhinitis
6%
Blood creatinine phosphokinase increased
6%
Blood creatinine increased
6%
Respiratory tract infection
6%
Hyperuricaemia
6%
Myalgia
6%
Paraesthesia
6%
Pruritus
6%
Haematoma
6%
Hyperphosphataemia
6%
Rhinorrhoea
6%
Infection
3%
Vision blurred
3%
Upper Respiratory Tract Infection
3%
Oral herpes
3%
Disease progression
3%
Visual impairment
3%
Polyneuropathy
3%
Angina pectoris
3%
Confusional state
3%
Cardiac Failure
3%
Epistaxis
3%
Renal Failure
3%
Renal failure
3%
Spinal Stenosis
3%
Urinary tract infection
3%
Dry mouth
3%
Decreased appetite
3%
Back pain
3%
Erythema
3%
Petechiae
3%
Insomnia
3%
Hyponatraemia
3%
Spinal stenosis
3%
Fall
3%
Pneumonia
3%
Amylase increased
3%
Oropharyngeal pain
3%
Vertigo
3%
Neutrophilia
3%
Leukocytosis
3%
Pain
3%
Dysaesthesia
3%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: MOR03087 Biweekly Dose Escalation
Part B: MOR03087 Weekly Dose Escalation
Part C: MOR03087 Plus Dexamethasone
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Part E: MOR03087 Plus Lenalidomide + Dexamethasone

M-PLACE Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Patients with membranous nephropathy refractory to immunosuppressive treatment
Group II: Cohort 1Experimental Treatment1 Intervention
Patients with newly diagnosed or relapsed membranous nephropathy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MOR202
2019
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

HI-BioLead Sponsor
5 Previous Clinical Trials
152 Total Patients Enrolled
MorphoSys AGLead Sponsor
26 Previous Clinical Trials
6,629 Total Patients Enrolled
HI-Bio Clinical Program LeadStudy DirectorHI-Bio
4 Previous Clinical Trials
130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)
2019. "Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04145440.
~6 spots leftby Apr 2025
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