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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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%

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

Nasal congestion

Acute Kidney Injury

Dyspnoea exertional

Rhinitis

Blood creatinine phosphokinase increased

Blood creatinine increased

Respiratory tract infection

Hyperuricaemia

Myalgia

Paraesthesia

Pruritus

Haematoma

Hyperphosphataemia

Rhinorrhoea

Infection

Vision blurred

Upper Respiratory Tract Infection

Oral herpes

Disease progression

Visual impairment

Polyneuropathy

Angina pectoris

Confusional state

Cardiac Failure

Epistaxis

Renal Failure

Renal failure

Spinal Stenosis

Urinary tract infection

Dry mouth

Decreased appetite

Back pain

Erythema

Petechiae

Insomnia

Hyponatraemia

Spinal stenosis

Fall

Pneumonia

Amylase increased

Oropharyngeal pain

Vertigo

Neutrophilia

Leukocytosis

Pain

Dysaesthesia

Abdominal pain

100%

80%

60%

40%

20%

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

~30

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors (60+ years old) being considered for participation in this clinical research?

"Individuals aged 18-75 are eligible to participate in this trial. Subgroups of 12 minors and 42 seniors have been identified for specialized study protocols."

Answered by AI

How can Felzartamab be administered without adverse effects?

"The safety of Felzartamab is rated as a 1 according to our team at Power, which reflects its status in Phase 1 trials with limited data supporting efficacy and security."

Answered by AI

What is the upper threshold of participants for this research project?

"Affirmative. According to the information stored on clinicaltrials.gov, this clinical trial is actively looking for participants and was first posted on October 1st 2023 with its latest edit occurring a month later. The enrollment goal of this study is 20 patients from one medical site."

Answered by AI

Is there a possibility to enroll in this research endeavor presently?

"Affirmative. Currently posted on clinicaltrials.gov, this medical research is actively enrolling participants according to the information provided when it was initially uploaded on October 1st 2023 and revised by October 23rd of the same year. This study requires that 20 patients be recruited from one location."

Answered by AI

To whom is this trial open for enrollment?

"This research endeavour is currently attempting to enrol 20 eligible persons with Systemic Lupus Erythematosus (SLE) and International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN. Recipients must be between 18-75 years old, have a urine protein:creatinine ratio above 1 g/g, an estimated glomerular filtration rate that surpasses 45 mL/min per 1.73 meters squared, and evidence of inadequate response or intolerance to at least 3 months of conventional care for lupus nephritis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Felzartamab in Participants With Lupus Nephritis

2023. "A Study of Felzartamab in Participants With Lupus Nephritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064929.

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