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Monoclonal Antibodies

Felzartamab for IgA Nephropathy (IGNAZ Trial)

Phase 2

Waitlist Available

Research Sponsored by MorphoSys AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country

Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ongoing through study completion, up to 2 years

Awards & highlights

IGNAZ Trial Summary

This trial is testing a new drug for IgA Nephropathy, a kidney disease. The trial is comparing the new drug to a placebo, and is double-blind, meaning neither the patients nor the researchers know who is receiving which treatment.

Who is the study for?

Adults aged 18-80 with a biopsy-confirmed diagnosis of IgA Nephropathy (IgAN) within the last 8 years, who have been on maximum or maximally tolerated doses of blood pressure medication for at least 3 months. Women must not be pregnant or breastfeeding and agree to use contraception during and post-trial for three months. Excluded are individuals with certain low blood counts, diabetes type 1, or elevated liver enzymes.Check my eligibility

What is being tested?

The trial is testing Felzartamab, an anti-CD38 antibody against a placebo in patients with IgAN. It's randomized (participants are assigned by chance), double-blind (neither participants nor researchers know who gets what treatment), multi-center, and aims to see how effective and safe the drug is.See study design

What are the potential side effects?

Potential side effects of Felzartamab may include reactions related to the immune system since it targets CD38 proteins which play a role in immunity. Specific side effects aren't listed but could resemble those seen with other monoclonal antibodies such as infusion reactions or increased risk of infections.

IGNAZ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and of legal age.

Select...

I've been on the highest dose possible of ACEi or ARB for my blood pressure for over 3 months.

Select...

I am not pregnant or breastfeeding and agree to use contraception as advised for 3 months after the last treatment.

Select...

My kidney disease (IgAN) was confirmed by a biopsy in the last 8 years.

IGNAZ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: Relative change in Proteinuria value

Secondary outcome measures

Efficacy: Relative change in proteinuria value

Efficacy: complete response in patients with IgAN

Pharmacokinetic: serum concentrations of Felzartamab over time

+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%

Lymphopenia

16%

Musculoskeletal chest pain

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

Acute Kidney Injury

Dyspnoea exertional

Rhinitis

Nasal congestion

Blood creatinine phosphokinase increased

Blood creatinine increased

Respiratory tract infection

Hyperuricaemia

Myalgia

Paraesthesia

Pruritus

Haematoma

Hyperphosphataemia

Rhinorrhoea

Infection

Oral herpes

Upper Respiratory Tract Infection

Disease progression

Vision blurred

Polyneuropathy

Visual impairment

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

IGNAZ Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Felzartamab Arm #3Experimental Treatment1 Intervention

Group II: Felzartamab Arm #2Experimental Treatment1 Intervention

Group III: Felzartamab Arm #1Experimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

MorphoSys AGLead Sponsor

26 Previous Clinical Trials

6,606 Total Patients Enrolled

HI-BioLead Sponsor

5 Previous Clinical Trials

129 Total Patients Enrolled

HI-Bio Clinical Program LeadStudy DirectorHI-Bio

4 Previous Clinical Trials

107 Total Patients Enrolled

Media Library

Felzartamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05065970 — Phase 2

IgA Nephropathy Research Study Groups: Placebo, Felzartamab Arm #3, Felzartamab Arm #2, Felzartamab Arm #1

IgA Nephropathy Clinical Trial 2023: Felzartamab Highlights & Side Effects. Trial Name: NCT05065970 — Phase 2

Felzartamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065970 — Phase 2

Frequently Asked Questions

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

If I meet the requirements, may I sign up for this clinical trial?

"The requirements to join this clinical trial are that patients must have some form of kidney disease and be between 18-80 years old. Right now, the research team is seeking a total of 48 individuals."

Answered by AI

Does this trial have an age limit? If so, what is it?

"This particular trial is only for patients that fall in the age range of 18 to 80 years old. In contrast, there are 45 trials recruiting patients under 18 and another 470 trials seeking participants over 65."

Answered by AI

How does this new Felzartamab research compare to other scholarly work in the field?

"The first clinical trial for felzartamab occurred in 2019 at Peking Union Medical College Hospital. As of now, there are a total of 18290 completed clinical trials. Out of these, 7 are actively recruiting patients with many of these studies taking place in El Paso, Texas."

Answered by AI

How many guinea pigs are part of this test group?

"The sponsor, MorphoSys AG, needs a total of 48 patients that fit the bill in order to carry out this trial. The study will be conducted at different sites including MedResearch INC in El Paso, Texas and FOMAT Medical Research - FOMAT - HyperCore - PPDS in Oxnard, California."

Answered by AI

Are there still room for more participants in this research?

"The trial is still enrolling patients, as seen on clinicaltrials.gov. The original posting date was 8/31/2021, with the most recent update being 7/1/2022."

Answered by AI

Is this research study the first to ever explore this treatment option?

"I-Mab Biopharma Co. Ltd.'s 2019 Phase 2 clinical trial was the first study involving Felzartamab. 113 patients completed the drug approval process in that year. Since then, 18290 studies have been conducted across 21 countries and 68 cities."

Answered by AI

Does the FDA approve of Felzartamab?

"Felzartamab's safety is based on Phase 2 trial data, which only provides limited support for its use."

Answered by AI

Is this study popular in Canadian hospitals?

"There are 4 enrolling patients for this clinical trial including MedResearch INC in El Paso, FOMAT Medical Research - FOMAT - HyperCore - PPDS in Oxnard, and Amicis Research Center, Vacaville in Vacaville. There are also 4 other locations where this study is taking place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy

2021. "Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05065970.

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