A Phase 1/2 Study with Ascending Dose in order to Evaluate the Safety and Effects on Progranulin Levels of investigational product under code LY3884963 in Patients with Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN) (PROCLAIM)

Start 23 Mar 2026 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 4 sites · Protocol J4B-MC-OKAA

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruitment ended

Participants planned 43

Countries 2

Sites 4

Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN)

1. Evaluate the safety, tolerability, and immunogenicity of 3 dose levels of LY3884963 administered via suboccipital injection into the cisterna magna. 2. Quantify PGRN levels in blood and CSF.

Key facts

Sponsor: Prevail Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trial duration: 23 Mar 2026 → ongoing
Decision date (initial): 2024-08-05
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes
Funding sources: Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly & Company

External identifiers

EU CT number: 2022-502942-29-01
ClinicalTrials.gov: NCT04408625

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Dose response

1. Evaluate the safety, tolerability, and immunogenicity of 3 dose levels of LY3884963 administered via suboccipital injection into the cisterna magna.
2. Quantify PGRN levels in blood and CSF.

Secondary objectives 1

To evaluate the effect of LY3884963 on: • Clinical Dementia Rating staging instrument plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration domains (CDR® plus NACC FTLD). • Neurofilament light chain (NfL) levels in blood and CSF.

Conditions and MedDRA coding

Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN)

Version	Level	Code	Term	System organ class
21.1	PT	10068968	Frontotemporal dementia	100000004852

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Dose Finding Period Three initial dose-finding cohorts and a fourth bridging cohort	Not Applicable	None		Dose-escalating cohort 1: Low dose; 2.1 × 10^13 vg Dose-escalating cohort 2: Mid dose; 4.2 × 10^13 vg Dose-escalating cohort 3: High dose; 0 Bridging cohort 4: Low dose 2.1 × 10^13 vg or Mid dose: 4.2 × 10^13 vg Cohort 5

Regulatory references

Scientific advice from competent authorities: Swedish Medical Products Agency, Federal Agency For Medicines And Health Products
EMA paediatric investigation plan (PIP): EMEA-003374-PIP01-22
Plan to share IPD: Yes
IPD plan description: Study data collected as part of this research study may be published in a study report or scientific presentation. Information that identifies study participants or that reasonably could be used to identify study participants will not be included in such publications.

EU CT number	Title	Sponsor
2022-502942-29-00	A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients with Fronto-Temporal Dementia with Progranulin Mutations (FTD-GRN) (PROCLAIM)	Prevail Therapeutics Inc.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

Men or women aged 30 to 85 years (inclusive), at the time of informed consent.
Body weight range of ≥40 kg (88 lb) to ≤110 kg (242 lb) and a body mass index (BMI) of 18 to 34 kg/m2.
Has symptomatic frontotemporal dementia (FTD), including mild behavioral, cognitive, motor or language impairment per Investigator’s assessment (behavioral-variant FTD, primary progressive aphasia-FTD, FTD with corticobasal syndrome, or a combination of syndromes are allowed for enrollment).
Score ≥0.5 and ≤15 on CDR plus NACC FTLD sum of boxes (Cohorts 1-4 only). Note: In Cohort 5 only patients with CDR plus NACC FTLD with sum of boxes ≥0.5 and ≤9 AND global score of 0.5 or 1 will be enrolled.
Stable use of background medications at least 8 weeks prior to LY3884963 dosing.
Carrier of a pathogenic progranulin gene (GRN) mutation confirmed by the central laboratory.
Negative screening test for Mycobacterium tuberculosis (MTB) or documented negative MTB test within 1 year prior to Screening.
Age- and gender-appropriate cancer screenings are up to date and completed per the Investigator's judgment and local standard of care prior to Screening.
Patient and/or patient’s legally authorized representative (LAR) (where applicable by local regulation) has the ability to understand the purpose and risks of the study, and provide written informed consent and authorization to use protected health information in accordance with national and local privacy regulations.
Patient has a reliable study partner/informant (e.g., family member, friend) willing and able to participate in the study as a source of information on the patient’s health status and cognitive and functional abilities (including providing input into the rating scales).
Patient is generally ambulatory and not dependent on a walker or wheelchair.
Patient is living in the community (i.e. not in a nursing home); some levels of assisted living may be permitted at the Investigator's discretion.
Pneumococcal pneumonia and shingles vaccines are required within 10 years of Screening (allowed to be performed during Screening but must be given at least 4 weeks prior to initiation of immunosuppressant regimen).

Exclusion criteria 13

Diagnosis of a significant central nervous system (CNS) disease other than FTD that may be a cause for the patient's FTD symptoms or may confound study objectives.
Brain or cervical spine magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA) imaging indicating clinically significant abnormality considered to prevent intracisternal magna (ICM) injection.
Hypersensitivity or contraindications to corticosteroid, and/or sirolimus use (including, but not limited to, osteoporosis with vertebral fractures within 1 year prior to Screening, poorly controlled diabetes, uncontrolled hypertension, and uncontrolled hyperlipidemia or hypercholesterolemia per Investigator’s assessment).
Clinical evidence of peripheral symmetric sensory polyneuropathy (stable sensory mononeuropathies and radiculopathies are not exclusionary).
Concomitant disease or condition within 6 months of Screening that could interfere with, or treatment of which might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable safety risk to the patient or interfere with the patient's ability to comply with study procedures.
Clinically significant abnormalities in laboratory test results at Screening.
Participation within 3 months prior to Screening in another therapeutic investigational drug or device study with purported disease-modifying effects on FTD, unless it can be documented that the patient received placebo only.
Any type of prior gene or cell therapy.
Live vaccines in the 4 weeks prior to Screening. Note: Pneumococcal vaccine and/or shingles vaccine administration is allowed at least 4 weeks prior to initiation of immunosuppressant regimen.
Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) in the 2 weeks prior to Screening or the anticipated need to initiate blood thinners during the study. Antiplatelet therapies (prophylactic aspirin, clopidogrel) are acceptable if the patient is medically able to temporarily stop 48 hours to 7 days (depending on the antiplatelet medication used) prior to and at least 48 hours after ICM injection and LP. Note: the use of blood thinners as part of prophylaxis or treatment of an emergent VTE or another AE during the study does not exclude the patient, unless there is a baseline high risk of thromboembolic events, and use of blood thinners is highly anticipated in the opinion of the Investigator.
Contraindications or intolerance to imaging methods (MRI, MRA, and/or computed tomography [CT]), including claustrophobia and intolerance to contrast agents used for MRI, MRA, or CT (including, but not limited to, gadolinium contrast agents and iohexol).
Contraindications to general anesthesia or deep sedation.
Positive urine test for drugs of abuse (including opiates, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription at Screening and on Day -1.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

The following primary safety endpoints will be measured up to 5 years: • Incidence and severity of treatment-emergent adverse events and serious adverse events (see study protocol for details).
• For patients who received Sirolimus: treatment-emergent hypercholesterolemia or hyperlipidemia; treatment-emergent proteinuria; treatment-emergent interstitial lung disease; and sirolimus trough levels.
• For patients who received Rituximab: treatment-emergent hypogammaglobulinemia; and lymphocyte immunophenotyping.
• Incidence of procedure or treatment-emergent safety findings per brain and spine MRI.
• Change from baseline in immunogenicity of AAV9, PGRN, and NfL in blood and in CSF over time.
The following are the primary efficacy endpoints: • Change from baseline in PGRN levels in blood over time. • Change from baseline in PGRN levels in CSF over time.

Secondary endpoints 1

• Change from baseline in CDR plus NACC FTLD over time. • Change from baseline in NfL levels in blood over time. • Change from baseline in NfL levels in CSF over time.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Adeno-Associated Viral Vector Serotype 9 Expressing Codon-Optimized Human Grn Gene

PRD11375909 · Product

Active substance: Adeno-Associated Viral Vector Serotype 9 Expressing Codon-Optimized Human Grn Gene
Substance synonyms: PR006A, Adeno-associated viral vector serotype 9 expressing codon-optimized human progranulin gene
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRACISTERNAL USE
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/20/2359

Auxiliary 20

Rapamune 1 mg coated tablets

PRD3342103 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/008
MA holder: PFIZER EUROPE MA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD505929 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/014
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD505882 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/007
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD505968 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/013
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342089 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/013
MA holder: PFIZER EUROPE MA EEIG
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342163 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/013
MA holder: PFIZER EUROPE MA EEIG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sirolimus

SUB10537MIG · Substance

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD3342088 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/007
MA holder: PFIZER EUROPE MA EEIG
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD3342156 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/007
MA holder: PFIZER EUROPE MA EEIG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD3342091 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/008
MA holder: PFIZER EUROPE MA EEIG
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342131 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/014
MA holder: PFIZER EUROPE MA EEIG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD3342172 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/007
MA holder: PFIZER EUROPE MA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342176 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/013
MA holder: PFIZER EUROPE MA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342146 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/014
MA holder: PFIZER EUROPE MA EEIG
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD505932 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/008
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 0.5 mg coated tablets

PRD3342090 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/014
MA holder: PFIZER EUROPE MA EEIG
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rapamune 1 mg coated tablets

PRD3342153 · Product

Active substance: Sirolimus
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: L04AA10 — SIROLIMUS
Marketing authorisation: EU/1/01/171/008
MA holder: PFIZER EUROPE MA EEIG
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Solu-Medrol 1000 mg por és oldószer oldatos injekcióhoz

PRD453020 · Product

Active substance: Methylprednisolone
Substance synonyms: 6-METHYLPREDNISOLONE
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Authorisation status: Authorised
ATC code: H02AB04 — METHYLPREDNISOLONE
Marketing authorisation: OGYI-T-2245/05
MA holder: PFIZER KFT.
MA country: Hungary
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisone Mylan Pharma 5 mg compresse

PRD3465897 · Product

Active substance: Prednisone
Pharmaceutical form: TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: H02AB — GLUCOCORTICOIDS
Marketing authorisation: 043412016
MA holder: MYLAN S.P.A.
MA country: Italy
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisona Cinfa 10 MG Comprimidos

PRD2845105 · Product

Active substance: Prednisone
Pharmaceutical form: TABLET
Route of administration: ORAL
Authorisation status: Authorised
ATC code: H02AB — GLUCOCORTICOIDS
Marketing authorisation: 75.649
MA holder: LABORATORIOS CINFA, S.A.
MA country: Spain
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Prevail Therapeutics Inc.

Sponsor organisation: Prevail Therapeutics Inc.
Address: 645 Summer Street
City: Boston
Postcode: 02210-2135
Country: United States

Scientific contact point

Organisation: Prevail Therapeutics Inc.
Contact name: Regulatory Department

Public contact point

Organisation: Prevail Therapeutics Inc.
Contact name: Regulatory Department

Third parties 14

Organisation	City, country	Duties
QPS LLC ORG-100012847	Newark, United States	Laboratory analysis
PPD Development LP ORG-100011560	Wilmington, United States	On site monitoring, Code 10, Code 11, Code 12, Code 5, Data management, E-data capture
University College London ORG-100006526	London, United Kingdom	Laboratory analysis
Unisphere Travel Ltd. Inc. ORG-100043100	Stamford, United States	Other
Bioagilytix Labs LLC ORG-100013030	Boston, United States	Laboratory analysis
Nextcea Inc. ORG-100041657	Woburn, United States	Laboratory analysis
WCG Clinical Inc. ORG-100040730	Princeton, United States	Other
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Laboratory analysis
Centogene GmbH ORG-100043695	Rostock, Germany	Laboratory analysis
Quanterix Corp. ORG-100044008	Billerica, United States	Laboratory analysis
Bioclinica Inc. ORG-100033079	Princeton, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Highland Heights, United States	Laboratory analysis
Labcorp Early Development Laboratories Limited ORL-000012554	Greenfield, United States	Laboratory analysis

Locations

2 EU/EEA countries · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruitment ended	5	1
France	Ended	8	3
Rest of world Australia, United States, United Kingdom	—	30	—

Investigational sites

Belgium

1 site · Ongoing, recruitment ended

UZ Leuven

Neurology, Herestraat 49, 3000, Leuven

France

3 sites · Ended

Centre Hospitalier Regional De Marseille

Hopital de la Timone Neurologie et Neuropsychologie Pole de Neurosciences Cliniques, 264 Rue Saint Pierre, 13005, Marseille

Centre Hospitalier Universitaire De Lille

Hopital Roger Salengro Centre Memoire de Ressources et de Recherches, Boulevard Du Professeur Jules Leclercq, 59000, Lille

Assistance Publique Hopitaux De Paris

Institut du Cerveau et de la Moelle Epinière CIC Neurosciences Batiment de l'ICM, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

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
Belgium	2024-08-05		2024-08-05	2026-02-04
France	2024-08-13	2026-03-24	2024-08-13	2026-02-04

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Temporary halt TH-110183

Halt date: 2025-02-05
Member states concerned: Belgium
Publication date: 2025-12-11
Reason: Sponsor decision, Safety related (clinical or pre-clinical results)
Explanation: Assay-related issues causing under-recovery of CSF PGRN in study participants. Non-invasive screening to continue, but administration of LY3884963 paused pending investigation and determination of any potential impact to benefit-risk profile.
Follow-up measures: All study participants administered LY3884963 will continue to be monitored for safety.
Benefit-risk balance changed: No
Treatment stopped: Yes

Temporary halt TH-110182

Halt date: 2025-02-05
Member states concerned: France
Publication date: 2025-12-11
Reason: Sponsor decision, Safety related (clinical or pre-clinical results)
Explanation: Assay-related issues causing under-recovery of CSF PGRN in study participants. Non-invasive screening to continue, but administration of LY3884963 paused pending investigation and determination of any potential impact to benefit-risk profile.
Follow-up measures: All study participants administered LY3884963 will continue to be monitored for safety.
Benefit-risk balance changed: No
Treatment stopped: Yes

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 68 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol_2022-502942-29-01_Public	10.4
Protocol (for publication)	D4_Prevail_J4B_MC_OKAA_Patient Facing Documents_Placeholder_Public	1.0
Recruitment arrangements (for publication)	K1_J4B-MC-OKAA_Recruitment_and_Informed_Consent_Procedure_BE_English_Public	1.0
Recruitment arrangements (for publication)	K1_J4B-MC-OKAA_Recruitment-and-Informed-Consent-Procedure_FRA_French_Public	1.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Caregiver Insert_BE_Dutch_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Caregiver Insert_BE_English_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Caregiver Insert_BE_French_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_CAREGIVER-INSERT_FRA_French_Clean_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_ICF_Flipchart_BE_Dutch_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_ICF_Flipchart_BE_English_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_ICF_Flipchart_BE_French_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_ICF-Flipchart_FRA_French_Clean_Public	3.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Immunosuppressant_Fact_Sheet_BE_Dutch_Public	2.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Immunosuppressant_Fact_Sheet_BE_English_Public	2.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Immunosuppressant_Fact_Sheet_BE_French_Public	2.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_IMMUNOSUPPRESSANT-FACT-SHEET_FRA_French_Clean_Public	2.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_IP_Brochure_BE_Dutch_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_IP_Brochure_BE_English_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_IP_Brochure_BE_French_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_IP-BROCHURE_FRA_French_Clean_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Patient letter_BE_Dutch_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Patient letter_BE_English_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_Patient letter_BE_French_Public	4.0
Recruitment arrangements (for publication)	K2_J4B-MC-OKAA_PATIENT-LETTER_FRA_French_Clean_Public	4.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Genetic_Testing_ICF_Admin_Change_1_FRA_FR_Public	3.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Main_ICF_FRA_FR_Public	13.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Main-ICF_BE_Dutch_Public	13.0.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Main-ICF_BE_English_Public	13.0.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Main-ICF_BE_French_Public	13.0.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_MEMO_ICF versions_PA10_3_BE_English_Public	n/a
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_MEMO-ICF-versions-for-PA10_3_FRA_Public	n/a
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Participating Partner ICF_FRA_FR_Public	8.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Participating-Partner-ICF_BE_Dutch_Public	8.0.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Participating-Partner-ICF_BE_English_Public	8.0.0
Subject information and informed consent form (for publication)	L1_J4B-MC-OKAA_Participating-Partner-ICF_BE_French_Public	8.0.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Appointment Card_BE_Dutch_Public	3.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Appointment Card_BE_English_Public	3.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Appointment Card_BE_French_Public	3.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_APPOINTMENT-CARD_FRA_French_Public	3.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Branded Card_BE_Dutch_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Branded Card_BE_English_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Branded Card_BE_French_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_BRANDED-CARD_FRA_French_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Quickvisistguide_BE_Dutch_Public	4.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Quickvisistguide_BE_English_Public	4.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Quickvisistguide_BE_French_Public	4.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_QUICKVISITGUIDE_FRA_French_Clean_Public	4.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Safety Card_BE_Dutch_Public	5.1
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Safety Card_BE_English_Public	5.1
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Safety Card_BE_French_Public	5.1
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_SAFETY-CARD_FRA_French_Clean_Public	5.1
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Study Folder_BE_Dutch_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Study Folder_BE_English_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Study Folder_BE_French_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_STUDY-FOLDER_FRA_French_Public	1.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Visit Guide_BE_Dutch_Public	5.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Visit Guide_BE_English_Public	5.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_Visit Guide_BE_French_Public	5.0
Subject information and informed consent form (for publication)	L2_J4B-MC-OKAA_VISIT-GUIDE_FRA_French_Clean_Public	5.0
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis Lay Language_2022-502942-29-01_BE_DEU_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis Lay Language_2022-502942-29-01_BE_FRE_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis Lay Language_2022-502942-29-01_BE_NLD_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis Lay Language_2022-502942-29-01_FR_FRE_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis Lay Language_2022-502942-29-01_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis_2022-502942-29-01_BE_DEU_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis_2022-502942-29-01_BE_FRE_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis_2022-502942-29-01_BE_NLD_Public	10.3
Synopsis of the protocol (for publication)	D1_Prevail_J4B-MC-OKAA_Protocol Synopsis_2022-502942-29-01_FR_FRE_Public	10.3

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-07-09	Belgium	Acceptable with conditions 2024-08-05	2024-08-05
2	SUBSTANTIAL MODIFICATION	SM-1	2024-12-18	Belgium	Acceptable 2025-04-15	2025-04-15
3	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-11-07	Belgium	Acceptable 2025-04-15	2025-11-07
4	NON SUBSTANTIAL MODIFICATION	NSM-3	2025-11-25	Belgium	Acceptable 2025-04-15	2025-11-25
5	NON SUBSTANTIAL MODIFICATION	NSM-4	2025-11-26		Acceptable 2025-04-15	2025-11-26
6	SUBSTANTIAL MODIFICATION	SM-2	2025-12-12	Belgium	Acceptable 2026-03-23	2026-03-23
7	NON SUBSTANTIAL MODIFICATION	NSM-5	2026-05-12	Belgium	Acceptable 2026-03-23	2026-05-12