Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
126
Countries
3
Sites
27
Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)
To evaluate the efficacy of ALXN2050 to reduce proteinuria in participants with LN or IgAN
Key facts
- Sponsor
- Alexion Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Apr 2022 → 9 Dec 2024
- Decision date (initial)
- 2024-05-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Alexion Pharmaceuticals, Inc., United States
External identifiers
- EU CT number
- 2023-504825-38-00
- EudraCT number
- 2021-001426-22
- ClinicalTrials.gov
- NCT05097989
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Others, Safety
To evaluate the efficacy of ALXN2050 to reduce proteinuria in participants with LN or IgAN
Secondary objectives 1
- •To evaluate the efficacy of ALXN2050 to improve measures of kidney function in participants with LN or IgAN • PK/PD - To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of ALXN2050 in participants with LN or IgAN • Safety -To characterize the safety and tolerability of ALXN2050 in participants with LN or IgAN LN Cohort only: •To evaluate the efficacy of ALXN2050 on measures of kidney function in participants with LN IgAN Cohort Only: •To evaluate the efficacy of ALXN2050 on measures of kidney function in participants with IgAN
Conditions and MedDRA coding
Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
| 20.0 | PT | 10021263 | IgA nephropathy | 100000004857 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- LN Cohort • Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria. • Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease. Participants with de novo or relapsing disease may be eligible. • Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator. • Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period. IgAN Cohort • Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period. • Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period. • For participants with a kidney biopsy performed > 1 year prior to Screening that was used for eligibility: Presence of hematuria as defined by a positive result for blood on urine dipstick or ≥ 10 red blood cells (RBCs)/high power field (hpf) microscopy on urine sediment (documented by the local laboratory) during Screening Period. Presence of hematuria documented by the central laboratory may also be acceptable. • Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the Blinded Treatment Periods (through Week 50) (participants with established intolerance to RAS inhibitors may be included). • Controlled and stable blood pressure (defined as < 140/90 millimeters of mercury [mmHg]) over the past 3 months prior to randomization
Exclusion criteria 1
- Both Cohorts: • eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration. • For participants with eGFR < 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior to or during the Screening Period: a. ≥ 50% interstitial fibrosis and tubular atrophy b. ≥ 50% glomerular sclerosis c. ≥ 50% active crescent formation • Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period. • History of solid organ or bone marrow transplant, or planned transplant during the Blinded Extended Treatment Period (50 weeks). • Splenectomy or functional asplenia. • Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN). • Bone marrow insufficiency with absolute neutrophil count < 1.3 × 10^3/microliter; thrombocytopenia (platelet count < 50,000/cubic millimeter). For LN Cohort: • Participants who have initiated any of the following treatments for the current active LN flare: a. Cyclophosphamide ≤ 6 months prior to Screening b. CNIs ≤ 1 month prior to Screening c. A cumulative dose of intravenous (IV) methylprednisolone > 3 g d. Mycophenolate mofetil > 2 g/day (or equivalent) for ≥ 8 consecutive weeks prior to Screening e. Prednisone or prednisone equivalent ≥ 0.5 mg/kg/day for ≥ 8 consecutive weeks prior to Screening • Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg) on 2 or more measurements during the Screening Period. For IgAN Cohort: • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period. • Secondary etiologies of IgAN. • Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring treatment • Prednisone or prednisone equivalent > 20 mg/day for > 14 consecutive days or any other systemic immunosuppression for the treatment of IgAN ≤ 6 months prior to Screening • Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures > 30 minutes apart. • Body mass index ≥ 38 kg/m2 during Screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage change in proteinuria
Secondary endpoints 1
- 1) Percentage change in proteinuria 2) Achieving > 30% and > 50% reduction in proteinuria 3)Change from baseline in eGFR 4)PK/PD - Observed plasma concentrations of ALXN2050 5)PK/PD - Absolute values and change from baseline in plasma Bb concentration and serum AP activity 6) Safety - Incidence of TEAEs and TESAEs 7) Safety - Changes from baseline in laboratory assessments LN Cohort Only: 8) Meeting the criteria for complete renal response (CRR) 9) Meeting the criteria for partial renal response
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10934684 · Product
- Active substance
- Vemircopan
- Substance synonyms
- (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1h-indazol-1-yl)acetyl)-n-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo(3.1.0)hexane-3-carboxamide, (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide, ACH-5228, ACH-0145228, ALXN2050
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 154 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALEXION PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alexion Pharmaceuticals Inc.
- Sponsor organisation
- Alexion Pharmaceuticals Inc.
- Address
- 121 Seaport Boulevard
- City
- Boston
- Postcode
- 02210-2050
- Country
- United States
Scientific contact point
- Organisation
- Alexion Pharmaceuticals Inc.
- Contact name
- European Clinical Trial Information
Public contact point
- Organisation
- Alexion Pharmaceuticals Inc.
- Contact name
- European Clinical Trial Information
Third parties 18
| Organisation | City, country | Duties |
|---|---|---|
| PPD (Netherlands) B.V. ORG-100007129
|
Bennekom, Netherlands | Interactive response technologies (IRT), Data management, E-data capture |
| Pharma Start LLC ORG-100042396
|
Chicago, United States | Other |
| Alliance Pharma Inc. ORG-100046000
|
Malvern, United States | Other |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Code 14 |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other, Laboratory analysis |
| Mayo Collaborative Services LLC ORG-100046687
|
Rochester, United States | Other |
| Arup Laboratories Inc. ORG-100041750
|
Salt Lake City, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 11, Code 12, Code 8 |
| Nephropathology Associates PLC ORG-100044668
|
Little Rock, United States | Other |
| QPS LLC ORG-100012847
|
Newark, United States | Other |
| The Regents Of The University Of Colorado ORG-100032549
|
Aurora, United States | Other |
| Alexion Pharmaceuticals Inc. ORG-100006294
|
New Haven, United States | Other |
| Pyxant Labs Inc. ORG-100044673
|
Colorado Springs, United States | Other |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14, Other |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Almac Clinical Services (Ireland) Limited ORG-100033336
|
Dundalk, Ireland | Code 14, Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Code 11 |
Locations
3 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 9 |
| Italy | Ended | 15 | 8 |
| Spain | Ended | 10 | 10 |
| Rest of world
Turkey, Argentina, Serbia, China, United States, Brazil, United Kingdom, Mexico, Australia, Korea, Republic of, Peru, Thailand, Israel, Taiwan
|
— | 91 | — |
Investigational sites
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
I. Medizinische Klinik und Poliklinik-Nephrologie, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum der Universitaet Muenchen AöR
Nephrologisches Zentrum - Medizinische Klinik und Poliklinik IV, Marchioninistrasse 15, Hadern, Munich
Klinikum Fulda gAG
Universitätsmedizin Marburg - Campus Fulda, Medizinische Klinik III, Pacelliallee 4, Ziehers-Sued, Fulda
Universitat Heidelberg
V. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Essen AöR
Klinik für Infektiologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Essen AöR
Klinik für Nephrologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik I, Ratzeburger Allee 160, 23538, Luebeck
Medizinische Hochschule Hannover
Studienzentrum für Nieren- und Hochdruckerkrankungen, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
U.O.C. Immunoreumatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O. Nefrologia, Piazzale Spedali Civili 1, 25123, Brescia
University Hospital Consorziale Policlinico
Nephrology, Dialysis and Transplantation Unit, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.C. Nefrologia, Via Sergio Pansini 5, 80131, Naples
Ospedale San Giovanni Bosco
ScdU Nefrologia e Dialisi - CMID, Piazza Del Donatore Di Sangue 3, 10154, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Struttura Complessa di Nefrologia, Dialisi e Trapianto, Via Pietro Albertoni 15, 40138, Bologna
Ospedale San Raffaele S.r.l.
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, Via Olgettina 60, 20132, Milan
San Camillo Forlanini Hospital
UOC Reumatologia, Circonvallazione Gianicolense 87, 00152, Rome
University Hospital Son Espases
Glomerular Diseases, Carretera Valldemossa 79, 07120, Palma
Hospital Del Mar
Nephrology and Kidney Transplant, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Regional De Malaga
Nephorlogy, Avenida De Carlos De Haya Sn, 29010, Malaga
Bellvitge University Hospital
Nephrology, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
Nephrology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Fundacio Puigvert
Nephrology, Calle De Cartagena 340-350, 08025, Barcelona
Hospital General Universitario Gregorio Maranon
Nephrology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital General Universitario Reina Sofia
Nephrology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitari De Girona Doctor Josep Trueta
Nephrology, Avinguda De Franca S/n, 17007, Girona
University Hospital Virgen Del Rocio S.L.
Nephrology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-07-20 | 2022-12-14 | 2024-09-06 | ||
| Italy | 2022-04-15 | 2022-09-20 | 2024-09-06 | ||
| Spain | 2022-08-26 | 2022-11-09 | 2024-09-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-45967
- Halt date
- 2024-09-06
- Member states concerned
- Germany
- Publication date
- 2024-09-12
- Reason
- Sponsor decision
- Explanation
- On 26 August 2024, a participant with LN enrolled in Study ALXN2050-NEPH-201 died after experiencing an unexpected SAE of jaundice with elevated liver function tests (LFTs) on 15 August 2024. An ad-hoc Data Monitoring Committee (DMC) meeting was held on 30 August 2024 to review the case. A second ad-hoc meeting with the DMC was held on 03 September 2024 to review additional details and information. The DMC recommendation is to pause the administration of the ALXN2050 investigational product until additional information is available.
Alexion is enacting a pause in dosing participants in study ALXN2050-NEPH-201, as a precautionary measure in alignment with the DMC recommendation, with immediate effect as of 06 September 2024, while the causality of the fatal SAE is further investigated. - Follow-up measures
- All investigators have been informed of this safety event on the 6th of September 2024. Any additional follow-up information related to this event will be provided to Investigators. Sites are instructed to communicate with their patients immediately and no later than one business day following receipt of the investigator notification letter to inform them that dosing of the investigational product should be immediately paused.
As of 6th September 2024, the Interactive Web Response System (IWRS) will not allow any patient randomizations or dispensations of Investigational Product. Patients are instructed to return their Investigational Product at their next scheduled study visit as per the Schedule of Activities.
The following actions are implemented with immediate effect:
• No additional participants will be screened or randomized into the study
• Participants in the Treatment Period will have no additional doses administered while they continue to complete study assessments as outlined in the Schedule of Activities
• Participants in the Safety Follow-up Period will continue to be followed as per Schedule of Activities
In addition, if the participant’s next scheduled visit is greater than 30 days from the time of last dose following the dosing pause, an unscheduled visit should be conducted within 30 days from the last dose. During this unscheduled visit, the same assessments should be performed as per the Safety Follow-Up Visit in the Schedule of Activities.
Alexion is notifying Regulatory Authorities about the dosing pause in alignment with local guidelines. EC/IRBs will be notified about the dosing pause per the site’s IRB / EC guidelines. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-45965
- Halt date
- 2024-09-06
- Member states concerned
- Italy
- Publication date
- 2024-09-12
- Reason
- Sponsor decision
- Explanation
- On 26 August 2024, a participant with LN enrolled in Study ALXN2050-NEPH-201 died after experiencing an unexpected SAE of jaundice with elevated liver function tests (LFTs) on 15 August 2024. An ad-hoc Data Monitoring Committee (DMC) meeting was held on 30 August 2024 to review the case. A second ad-hoc meeting with the DMC was held on 03 September 2024 to review additional details and information. The DMC recommendation is to pause the administration of the ALXN2050 investigational product until additional information is available.
Alexion is enacting a pause in dosing participants in study ALXN2050-NEPH-201, as a precautionary measure in alignment with the DMC recommendation, with immediate effect as of 06 September 2024, while the causality of the fatal SAE is further investigated. - Follow-up measures
- All investigators have been informed of this safety event on the 6th of September 2024. Any additional follow-up information related to this event will be provided to Investigators. Sites are instructed to communicate with their patients immediately and no later than one business day following receipt of the investigator notification letter to inform them that dosing of the investigational product should be immediately paused.
As of 6th September 2024, the Interactive Web Response System (IWRS) will not allow any patient randomizations or dispensations of Investigational Product. Patients are instructed to return their Investigational Product at their next scheduled study visit as per the Schedule of Activities.
The following actions are implemented with immediate effect:
• No additional participants will be screened or randomized into the study
• Participants in the Treatment Period will have no additional doses administered while they continue to complete study assessments as outlined in the Schedule of Activities
• Participants in the Safety Follow-up Period will continue to be followed as per Schedule of Activities
In addition, if the participant’s next scheduled visit is greater than 30 days from the time of last dose following the dosing pause, an unscheduled visit should be conducted within 30 days from the last dose. During this unscheduled visit, the same assessments should be performed as per the Safety Follow-Up Visit in the Schedule of Activities.
Alexion is notifying Regulatory Authorities about the dosing pause in alignment with local guidelines. EC/IRBs will be notified about the dosing pause per the site’s IRB / EC guidelines. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-45963
- Halt date
- 2024-09-06
- Member states concerned
- Spain
- Publication date
- 2024-09-12
- Reason
- Sponsor decision
- Explanation
- On 26 August 2024, a participant with LN enrolled in Study ALXN2050-NEPH-201 died after experiencing an unexpected SAE of jaundice with elevated liver function tests (LFTs) on 15 August 2024. An ad-hoc Data Monitoring Committee (DMC) meeting was held on 30 August 2024 to review the case. A second ad-hoc meeting with the DMC was held on 03 September 2024 to review additional details and information. The DMC recommendation is to pause the administration of the ALXN2050 investigational product until additional information is available.
Alexion is enacting a pause in dosing participants in study ALXN2050-NEPH-201, as a precautionary measure in alignment with the DMC recommendation, with immediate effect as of 06 September 2024, while the causality of the fatal SAE is further investigated. - Follow-up measures
- All investigators have been informed of this safety event on the 6th of September 2024. Any additional follow-up information related to this event will be provided to Investigators. Sites are instructed to communicate with their patients immediately and no later than one business day following receipt of the investigator notification letter to inform them that dosing of the investigational product should be immediately paused.
As of 6th September 2024, the Interactive Web Response System (IWRS) will not allow any patient randomizations or dispensations of Investigational Product. Patients are instructed to return their Investigational Product at their next scheduled study visit as per the Schedule of Activities.
The following actions are implemented with immediate effect:
• No additional participants will be screened or randomized into the study
• Participants in the Treatment Period will have no additional doses administered while they continue to complete study assessments as outlined in the Schedule of Activities
• Participants in the Safety Follow-up Period will continue to be followed as per Schedule of Activities
In addition, if the participant’s next scheduled visit is greater than 30 days from the time of last dose following the dosing pause, an unscheduled visit should be conducted within 30 days from the last dose. During this unscheduled visit, the same assessments should be performed as per the Safety Follow-Up Visit in the Schedule of Activities.
Alexion is notifying Regulatory Authorities about the dosing pause in alignment with local guidelines. EC/IRBs will be notified about the dosing pause per the site’s IRB / EC guidelines. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| ALXN2050-NEPH-201_Summary of Results SUM-94984
|
2025-08-21T12:04:30 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| ALXN2050-NEPH-201_Lay Person Summary of Results | 2025-08-21T12:06:40 | Submitted | Laypersons Summary of Results |
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ALXN2050-NEPH-201_Lay Person Summary of Results_DE-DE | N/A |
| Laypersons summary of results (for publication) | ALXN2050-NEPH-201_Lay Person Summary of Results_EN | N/A |
| Laypersons summary of results (for publication) | ALXN2050-NEPH-201_Lay Person Summary of Results_ES-ES | N/A |
| Laypersons summary of results (for publication) | ALXN2050-NEPH-201_Lay Person Summary of Results_IT-IT | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_blank form_IT | N/A |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main IgAN_IT redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main LN_IT redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Kidney Biopsy_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main IgAN_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main LN_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional FSR_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Scout Clinical Pre-ICF Telephone Data Consent | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_IT | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Kidney Biopsy_IT | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and Birth_IT | 2.1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Material_GP Letter IgAN IT redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Material_GP Letter LN IT redacted | 2.1.0 |
| Summary of results (for publication) | ALXN2050-NEPH-201_Abbreviated CSR_redacted | 1.0 |
| Summary of results (for publication) | ALXN2050-NEPH-201_Summary of Results | N/A |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-22 | Germany | Acceptable 2024-05-16
|
2024-05-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Acceptable | 2025-02-20 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Acceptable | 2025-02-10 |