IgA Nephropathy (IgAN) MedDRA version: 23.1 Level: PT Classification code 10084204 Term: Sickle cell nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Felzartamab
Product Code: MOR202
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Felzartamab
CAS Number: 2197112-39-1
Current Sponsor code: MOR
Sponsors
MorphoSys AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients = 18 to = 80 years (at date of signing the informed consent form [ICF]), but at least of legal age in the given country 2. Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF 3. Proteinuria at screening visit = 1.0 g/d 4. 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 (recommended BP is =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits (e.g. Lupus nephritis, Schönlein-Henoch purpura, ankylosing spondylitis, dermatitis herpetiformis, chronic liver disease, inflammatory bowel disease, celiac disease). 2. Severe renal impairment as defined by estimated GFR 35 kg/m^2. 9. Hemoglobin 1.5 x ULN, alkaline phosphatase >3.0 x ULN. 19. Known or suspected hypersensitivity to Felzartamab and its excipients (L-histidine, sucrose, polysorbate 20). 20. Serologic markers positive for HIV or history of HIV, hepatitis C (patients with positive anti-hepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen [HBsAg] are excluded). For patients with positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll). 21. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or other non-melanomatous skin cancer. 22. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to Visit 2, whatever is longer) with investigational drugs. 23. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the change in urine protein to creatinine ratio (UPCR) at 9 months.;Secondary Objective: To assess the relationship between exposure, safety, and efficacy in each of the three dose groups vs. placebo to support a decision for a dose in further trials To assess the efficacy of Felzartamab compared to placebo in patients with IgAN based on the following: - Change in UPCR at 3, 6, 12, 18 and 24 months - Complete response (CR) at 3, 6, 9, 12, 18 and 24 months - Proportion of patients with response at 3, 6, 9, 12, 18 and 24 months - Albumin-creatinine ratio (ACR) at 6, 9, 12, 18 and 24 months - Duration of response - Time to response To assess the renal function of Felzartamab compared to placebo in patients with IgAN. To assess the safety of Felzartamab in patients with IgAN. To assess the pharmacokinetic (PK) profile of Felzartamab in patients with IgAN. To investigate the potential immunogenicity of Felzartamab in patients with IgAN;Primary end point(s): Relative change in UPCR in 24h urine compared to the reference proteinuria value in the Felzartamab dose groups vs. placebo.;Timepoint(s) of evaluation of this end point: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Integrative analysis of several endpoints. Relative change in UPCR in 24h urine compared to the reference proteinuria value in each Felzartamab dose group vs. placebo. Complete response in each Felzartamab dose group vs. placebo. Proportion of patients with response in each Felzartamab dose group vs. placebo. Albumin-creatinine ratio from 24 h urine in each Felzartamab dose group vs. placebo. Duration of response in each Felzartamab dose group vs. placebo. Time to response in each Felzartamab dose group vs. placebo. Renal function (determined by estimated glomerular filtration rate [eGFR] over time) in each Felzartamab dose group vs. placebo. Frequency, incidence, seriousness, relatedness, and severity of treatment-emergent adverse events (TEAEs) across all treatment groups. Serum concentrations of Felzartamab over time in each Felzartamab dose group. Formation of anti-drug antibodies (ADAs) over time in all groups;Timepoint(s) of evaluation of this end point: The primary analysis will be performed after all randomized patients have completed their 9 month-visit or discontinued the trial earlier. The final analysis of all endpoints will be performed after all randomized patients have completed their last visit, or discontinued the trial earlier. The secondary endpoints will be assessed at 3, 6, 9, 12, 18, 24 months as defined per each in study protocol. | — |
Countries
Australia, Belgium, Bulgaria, Canada, Czechia, Georgia, Germany, Japan, Korea, Republic of, Malaysia, Philippines, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Program Medical Director
MorphoSys AG
Outcome results
None listed