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Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Placebo | Placebo Comparator | Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141. |
|
| Part 1: Felzartamab Dosing Arm M1 | Experimental | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141. |
|
| Part 1: Felzartamab Dosing Arm M2 | Experimental | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
|
| Part 1: Felzartamab Dosing Arm M3 | Experimental | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
| Part 2: Japan Cohort | Experimental | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felzartamab | Drug | anti-CD38+ monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 | Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. | Baseline, Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group | All felzartamab and placebo-treated participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only) were divided into exposure quartiles using the sum of measurable felzartamab Ctrough values up to 9 months after the first dose. Percent change from baseline in IgA concentration in these participants was summarized as per each serum concentration quartile. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | HI-Bio, A Biogen Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FOMAT Medical Research - FOMAT - HyperCore - PPDS | Oxnard | California | 93030 | United States | ||
| Amicis Research Center, Vacaville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40581166 | Derived | Floege J, Lafayette R, Barratt J, Schwartz B, Manser PT, Patel UD, Shah M, Kivman L, Faulhaber N, Kraft T, Thakur A, Hartle S, Barbour SJ. Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy. Kidney Int. 2025 Oct;108(4):695-706. doi: 10.1016/j.kint.2025.05.028. Epub 2025 Jun 26. | |
| 40465397 |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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A total of 54 participants diagnosed with Immunoglobulin A Nephropathy (IgAN) were enrolled in the study, of which 48 participants completed the study. The study had 2 parts - Part 1 (Global Cohort) and Part 2 (Japanese Cohort).
Participants were enrolled at investigative sites in Belgium, Bulgaria, Czechia, Georgia, Germany, Japan, Republic of Korea, Malaysia, Philippines, Serbia, Spain, Taiwan, Ukraine, and the United States from 31 August 2021 to 06 May 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Placebo | Participants were administered felzartamab matching placebo as an intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141. |
| FG001 | Part 1: Felzartamab Dosing Arm M1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2022 | Jan 30, 2026 |
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|
|
| Placebo | Other | Placebo comparator |
|
| Up to 9 months |
| Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose | All participants with evaluable maximum felzartamab concentrations after the first dose were included in the analysis. Cmax values were assessed by infusion-related reaction status after the first dose. | Up to 1 week |
| Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 | Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR will be estimated based on an MMRM model. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. | Baseline, Months 3,6,12,18 and 24 |
| Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 | CR was defined as the reduction of proteinuria to less than 0.3 g/g UPCR, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) (at least 80% of value at baseline visit). | Months 3,6,9,12,18 and 24 |
| Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 | Response was defined as reduction of proteinuria to below 0.6 g/g (UPCR) and stable eGFR (at least 80% of value at baseline visit), but not CR. | Months 3,6,9,12,18 and 24 |
| Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 | Months 6, 9,12,18 and 24 |
| Part 1: Duration of Response | Duration of response was defined as date of 1st observation of progressive disease minus date of 1st observation of response+1 day. Duration of response was estimated by Kaplan Meier method. | Up to 2 years |
| Part 1: Time to Response | Time to response was defined as date of 1st observation of response minus date of randomization+1 day. Time to response was estimated by Kaplan Meier method. | Up to 2 years |
| Change From Baseline in eGFR Over Time | eGFR was calculated as per the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. eGFR =141×min(Scr/κ, 1)α×max(Scr κ,1)-1.209×0.993Age ×1.018[if female]×1.159 [if black] where:
| Baseline, Months 3,6,9,12,15,18, and 24 |
| Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | TEAEs were defined as any AEs reported after the start of trial treatment until 28 days after the last trial treatment, defined as the treatment-emergent period. TESAEs were TEAEs that met the following criteria: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. | From the first dose until 28 days after last dose of study drug (up to 191 days) |
| Serum Concentrations of Felzartamab Over Time | Predose and 30 minutes post-dose on Days 1, 15, 29; predose on Days 8, 57, 85, 113, 141; Post Treatment Days 169 and 267 |
| Percentage of Participants With Anti- Felzartamab Antibodies | Blood samples were collected for measurement of anti-felzartamab antibodies in the serum. Number of participants with Anti-drug antibody (ADA) status positive/negative was summarized. | From the first dose up to the end of the study (up to 2 years) |
| Vacaville |
| California |
| 95687 |
| United States |
| Mayo Clinic Hospital - Methodist Campus | Rochester | Minnesota | 55902 | United States |
| MedResearch INC | El Paso | Texas | 79935 | United States |
| Core Research Group | Milton | Queensland | 4064 | Australia |
| Sunshine Hospital - Australia | Saint Albans | Victoria | Australia |
| Imelda VZW | Bonheiden | Antwerpen | Belgium |
| UZ Leuven Hospital | Leuven | Vlaams Brabant | 3000 | Belgium |
| Regionaal Ziekenhuis Jan Yperman VZW | Ieper | Belgium |
| CHU Sart Tilman Hospital | Liège | 4000 | Belgium |
| Diagnostic- Consultative Center Convex EOOD | Sofia | Sofia-Grad | 1680 | Bulgaria |
| Medical Center Hera EOOD, Montana | Montana | 3400 | Bulgaria |
| Medical Center Hipokrat- N EOOD | Plovdiv | 4000 | Bulgaria |
| University Multiprofile Hospital for Active Treatment | Stara Zagora | Bulgaria |
| Nemocnice AGEL Novy Jicin a.s | Nový Jicín | Moravian-Silesian Region | 741 01 | Czechia |
| Eticka komise Fakultni nemocnice Olomouc | Olomouc | Olomouc Region | 775 20 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady Hospital | Prague | Praha, Hlavní Mesto | 10034 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | Praha, Hlavní Mesto | 128 08 | Czechia |
| JSC Evex Hospitals | Tbilisi | 121 | Georgia |
| L. Managadze National Center of Urology LTD | Tbilisi | 144 | Georgia |
| Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies | Tbilisi | 144 | Georgia |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany |
| National Hospital Organization Chibahigashi National Hospital | Chiba | Chiba | 260-0801 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaidô | 060-8648 | Japan |
| Hospital of the University of Occupational and Environmental Health, Japan | Kitakyushu-Shi | Hukuoka | 807-8556 | Japan |
| Kurume University Hospital | Kurume-Shi | Hukuoka | 830-0011 | Japan |
| Fukushima Medical University Hospital | Fukushima | Hukusima | 960-1295 | Japan |
| JCHO Sendai Hospital | Sendai | Miyagi | 981-3205 | Japan |
| Japanese Red Cross Ashikaga Hospital | Ashikaga-Shi | Tochigi | 326-0843 | Japan |
| Juntendo University Hospital | Bunkyō-Ku | Tokyo | 113-8431 | Japan |
| Osaka University Hospital | Suita-Shi | Ôsaka | 565-0871 | Japan |
| University Malaya Medical Centre | Pantai | Malaysia |
| St Frances Cabrini Medical Center and Cancer Institute | Santo Tomas | Batangas | 4234 | Philippines |
| Clinical Centre of Vojvodina | Novi Sad | Vojvodina | 21000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11080 | Serbia |
| Clinical Hospital Centar Zvezdara | Belgrade | Serbia |
| General Hospital Krusevac | Kruševac | 37000 | Serbia |
| University Clinical Center Nis | Niš | 18000 | Serbia |
| Seoul National University Bundang Hospital | Seongnam | Gyeonggido | 13620 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggido | 16499 | South Korea |
| Konkuk University Medical Center | Seoul | Seoul Teugbyeolsi | 5030 | South Korea |
| The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Uijeongbu-si | South Korea |
| Fundacio Puigvert | Badalona | 8025 | Spain |
| Hospital Universitario Germans Trias i Pujol | Badalona | 8916 | Spain |
| Hospital del Mar | Barcelona | 8003 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 8035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital Universitari de Girona Dr Josep Trueta | Girona | Spain |
| Hospital Universitari Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital Ruber Juan Bravo (Grupo Quironsalud) | Madrid | Spain |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| Far Eastern Memorial Hospital | Taipei | 220 | Taiwan |
| Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council | Ternopil | Ternopil Oblast | 46002 | Ukraine |
| Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis" | Kyiv | Ukraine |
| State Institution Institute of Nephrology of NAMS of Ukraine | Kyiv | Ukraine |
| Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council | Zaporizhzhia | 69600 | Ukraine |
| Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772. |
| 40444214 | Derived | Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025. |
| 38299639 | Derived | Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. |
| 37772889 | Derived | El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29. |
Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141.
| FG002 | Part 1: Felzartamab Dosing Arm M2 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
| FG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| FG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants included all randomized participants from the full analysis set (FAS) plus all Japanese participants who were enrolled in Part 2. The FAS included participants randomized to Part 1 of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Placebo | Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141. |
| BG001 | Part 1: Felzartamab Dosing Arm M1 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141. |
| BG002 | Part 1: Felzartamab Dosing Arm M2 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
| BG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| BG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Urine Protein to Creatinine Ratio (UPCR) | Mean | Standard Deviation | gram per gram (g/g) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Relative Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) in 24-hour Urine at Month 9 | Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR was estimated based on mixed effects model for repeated measure (MMRM) model. Least squares (LS) mean and standard error (SE) were reported. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. | The full analysis set (FAS) included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis. The change from baseline in UPCR was planned to be analyzed in Part 1 only. | Posted | Least Squares Mean | Standard Error | gram per gram (g/g) | Baseline, Month 9 |
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| Secondary | Integrative Analysis of Several Endpoints: Percent Change From Baseline in Immunoglobulin A (IgA) Concentration by Predose Serum Concentration (Ctrough) Group | All felzartamab and placebo-treated participants with evaluable IgA data and felzartamab serum concentrations (in felzartamab-treated participants only) were divided into exposure quartiles using the sum of measurable felzartamab Ctrough values up to 9 months after the first dose. Percent change from baseline in IgA concentration in these participants was summarized as per each serum concentration quartile. | This outcome measure was planned to be analyzed for the overall participants irrespective of the group they were randomized to. Only those participants who had evaluable IgA data and felzartamab serum concentrations are reported as the overall number of participants analyzed. Number analyzed signifies the number of participants available for analysis for the specified category. | Posted | Mean | Standard Deviation | percent change | Up to 9 months |
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| Secondary | Integrative Analysis of Several Endpoints: Maximum Serum Concentrations (Cmax) as Per the Infusion-Related Reactions (IRRs) After the First Dose | All participants with evaluable maximum felzartamab concentrations after the first dose were included in the analysis. Cmax values were assessed by infusion-related reaction status after the first dose. | This outcome measure was planned to be analyzed for all the felzartamab-treated participants together, irrespective of the dose group they were randomized to. Overall number of participants analyzed signifies the number of participants with evaluable data up to week 1. Number analyzed signifies the number of participants available for analysis for the specified category. | Posted | Mean | Standard Deviation | µg/mL | Up to 1 week |
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| Secondary | Part 1: Relative Change From Baseline in UPCR in 24-hour Urine at Months 3, 6, 12, 18 and 24 | Proteinuria is high levels of protein in the urine and is measured by UPCR. Relative change in UPCR will be estimated based on an MMRM model. The reference proteinuria value before start of treatment is defined as the mean of the values determined at screening and prior to baseline (visit 2) predose (UPCR from 24h urine). Negative change from baseline indicates less proteinuria. | The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The change from baseline in UPCR was planned to be analyzed in Part 1 only. | Posted | Least Squares Mean | Standard Error | g/g | Baseline, Months 3,6,12,18 and 24 |
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| Secondary | Part 1: Number of Participants With Complete Response (CR) at Months 3, 6, 9, 12, 18 and 24 | CR was defined as the reduction of proteinuria to less than 0.3 g/g UPCR, serum albumin within the reference range of the central laboratory and stable estimated glomerular filtration rate (eGFR) (at least 80% of value at baseline visit). | The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The number of participants with complete response were planned to be analyzed in Part 1 only. | Posted | Count of Participants | Participants | Months 3,6,9,12,18 and 24 |
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| Secondary | Part 1: Percentage of Participants With Response at Months 3, 6, 9, 12, 18 and 24 | Response was defined as reduction of proteinuria to below 0.6 g/g (UPCR) and stable eGFR (at least 80% of value at baseline visit), but not CR. | The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The percentage of participants with response were planned to be analyzed in Part 1 only. | Posted | Number | percentage of participants | Months 3,6,9,12,18 and 24 |
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| Secondary | Part 1: Albumin-Creatinine Ratio (ACR) at Months 6, 9, 12, 18 and 24 | The FAS included all participants randomized to Part 1 of the study. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. The ACR was planned to be analyzed in Part 1 only. | Posted | Mean | Standard Deviation | milligrams per gram (mg/g) | Months 6, 9,12,18 and 24 |
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| Secondary | Part 1: Duration of Response | Duration of response was defined as date of 1st observation of progressive disease minus date of 1st observation of response+1 day. Duration of response was estimated by Kaplan Meier method. | The FAS included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. The duration of response was planned to be analyzed in Part 1 only. | Posted | Median | 95% Confidence Interval | days | Up to 2 years |
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| Secondary | Part 1: Time to Response | Time to response was defined as date of 1st observation of response minus date of randomization+1 day. Time to response was estimated by Kaplan Meier method. | The FAS included all participants randomized to Part 1 of the study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. The time to response was planned to be analyzed in Part 1 only. | Posted | Median | 95% Confidence Interval | days | Up to 2 years |
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| Secondary | Change From Baseline in eGFR Over Time | eGFR was calculated as per the chronic kidney disease epidemiology collaboration (CKD-EPI) equation. eGFR =141×min(Scr/κ, 1)α×max(Scr κ,1)-1.209×0.993Age ×1.018[if female]×1.159 [if black] where:
| All enrolled participants included all randomized participants from the FAS plus all Japanese participants who were enrolled in Part 2. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Baseline, Months 3,6,9,12,15,18, and 24 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | TEAEs were defined as any AEs reported after the start of trial treatment until 28 days after the last trial treatment, defined as the treatment-emergent period. TESAEs were TEAEs that met the following criteria: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. | Safety analysis set included all participants who received at least one dose of trial treatment. | Posted | Count of Participants | Participants | From the first dose until 28 days after last dose of study drug (up to 191 days) |
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| Secondary | Serum Concentrations of Felzartamab Over Time | PK analysis set included all participants with any available quantifiable felzartamab serum concentration data. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Predose and 30 minutes post-dose on Days 1, 15, 29; predose on Days 8, 57, 85, 113, 141; Post Treatment Days 169 and 267 |
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| Secondary | Percentage of Participants With Anti- Felzartamab Antibodies | Blood samples were collected for measurement of anti-felzartamab antibodies in the serum. Number of participants with Anti-drug antibody (ADA) status positive/negative was summarized. | The Immunogenicity analysis set included all participants with at least one ADA sample. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From the first dose up to the end of the study (up to 2 years) |
|
From signing of informed consent up to the end of the study (up to 24 months)
Safety analysis set included all participants who received at least one dose of trial treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Placebo | Participants were administered felzartamab matching placebo as an IV infusion on Days 1, 8, 15, 22, 29, 57, 85, 113 and 141. | 0 | 12 | 1 | 12 | 9 | 12 |
| EG001 | Part 1: Felzartamab Dosing Arm M1 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1 and 15, and felzartamab matching placebo on Days 8, 22, 29, 57, 85, 113 and 141. | 0 | 12 | 1 | 12 | 11 | 12 |
| EG002 | Part 1: Felzartamab Dosing Arm M2 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. | 0 | 11 | 1 | 11 | 9 | 11 |
| EG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. | 0 | 13 | 0 | 13 | 12 | 13 |
| EG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. | 0 | 6 | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Dedifferentiated liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Digestive enzyme abnormal | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Lipase abnormal | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 27 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 27 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Keratitis bacterial | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 27 | Systematic Assessment |
| |
| Articular calcification | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 27 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 27 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 27 | Systematic Assessment |
| |
| Adjustment disorder with anxiety | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27 | Systematic Assessment |
| |
| Device allergy | Immune system disorders | MedDRA 27 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 27 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27 | Systematic Assessment |
| |
| Presbyopia | Eye disorders | MedDRA 27 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 27 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2024 | Jan 30, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709267 | felzartamab |
Not provided
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Unknown |
|
|
In the MMRM model, the ratio of post baseline UPCR over baseline UPCR at month 9 in log scale was response variable, while baseline UPCR in log scale, treatment, visit, treatment by visit interaction were fixed effect covariates. |
| MMRM |
| 0.7599 |
| Geometric LS Mean Ratio |
| 0.92 |
| 2-Sided |
| 95 |
| 0.54 |
| 1.57 |
Geometric mean ratio of UPCR at post baseline over baseline between Part 1: Felzartamab M2 to Part 1: Placebo. |
| Superiority |
| In the MMRM model, the ratio of post baseline UPCR over baseline UPCR at month 9 in log scale was response variable, while baseline UPCR in log scale, treatment, visit, treatment by visit interaction were fixed effect covariates. | MMRM | 0.4165 | Geometric LS Mean Ratio | 0.82 | 2-Sided | 95 | 0.49 | 1.35 | Geometric mean ratio of UPCR at post baseline over baseline between Part 1: Felzartamab M3 to Part 1: Placebo. | Superiority |
|
|
|
Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141.
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141.
|
|
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| OG003 |
| Part 1: Felzartamab Dosing Arm M3 |
Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| OG002 | Part 1: Felzartamab Dosing Arm M2 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| OG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
Participants were administered felzartamab as an IV infusion based on their body weight on Days 1, 8,15, 29, and 57, and felzartamab matching placebo on Days 22, 85, 113 and 141. |
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| OG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| Part 2: Japan Cohort |
Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
|
| OG003 | Part 1: Felzartamab Dosing Arm M3 | Participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
| OG004 | Part 2: Japan Cohort | Japanese participants were administered felzartamab as an IV infusion based on their body weight on Days 1,8,15, 22, 29, 57, 85, 113 and 141. |
|
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