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Monoclonal Antibodies

Felzartamab for Lupus Nephritis

Phase 1
Recruiting
Research Sponsored by HI-Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria
Diagnosis of International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 1 year prior to or during screening, either with or without the presence of Class V LN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial studies a drug to treat Lupus Nephritis in people who haven't responded to other treatments.

Who is the study for?
This trial is for people with Lupus Nephritis who have tried at least one standard treatment without success. They must have a specific type of kidney inflammation diagnosed by biopsy within the last year, protein in their urine, and kidneys that are still working moderately well. People can't join if they have very fast-worsening kidney disease, more than half of their kidney filters scarred, are on or will need dialysis soon, or had an organ transplant.Check my eligibility
What is being tested?
The study is testing Felzartamab alongside usual treatments for Lupus Nephritis to see how safe it is and how well patients tolerate it. Participants will receive Felzartamab plus the standard care that's typically given for this condition.See study design
What are the potential side effects?
While not specified here, similar drugs often cause side effects like reactions where the drug enters the body (infusion reactions), infections due to a weakened immune system, nausea, headaches and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with SLE according to the 2019 EULAR/ACR criteria.
Select...
My kidney biopsy shows I have a specific type of lupus nephritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events
Secondary outcome measures
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from Baseline in Lupus Serologic Markers
Change from Baseline in Serum Creatinine
+7 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%
Constipation
13%
Plasma Cell Myeloma
13%
Neutropenia
13%
Dyspnoea
13%
Infusion-related reaction
13%
Bronchitis
13%
Vomiting
13%
Hypertension
10%
Cough
10%
Hypophosphataemia
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%
Rhinitis
6%
Dyspnoea exertional
6%
Nasal congestion
6%
Acute Kidney Injury
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%
Polyneuropathy
3%
Oral herpes
3%
Vision blurred
3%
Disease progression
3%
Angina pectoris
3%
Visual impairment
3%
Upper Respiratory Tract Infection
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: FelzartamabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Felzartamab
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

HI-BioLead Sponsor
5 Previous Clinical Trials
163 Total Patients Enrolled
HI-Bio Clinical Program LeadStudy DirectorHI-Bio
4 Previous Clinical Trials
141 Total Patients Enrolled
~11 spots leftby May 2025
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