Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
184
Countries
3
Sites
23
Alzheimer's disease (AD)
Primary objective: To evaluate the safety, tolerability, and amyloid reduction associated with ABBV-916 after repeated intravenous administrations in subjects with early AD.
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- completed 27 Jun 2024
- Decision date (initial)
- 2023-07-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-500691-59-00
- ClinicalTrials.gov
- NCT05291234
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Pharmacokinetic, Efficacy
Primary objective: To evaluate the safety, tolerability, and amyloid reduction associated with ABBV-916 after repeated intravenous administrations in subjects with early AD.
Conditions and MedDRA coding
Alzheimer's disease (AD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10078036 | Early onset familial Alzheimer's disease | 100000004850 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Randomized, Double-Blind, Placebo-Controlled to investigate safety and Efficacy of ABBV-916 There will be a Screening Period of up to 60 days, a Double-Blind Treatment Period of 24 weeks and a Follow-up Period of 16 weeks. The duration of the Extension Period will be approximately 2 years plus a 16-week Followup Period. The Screening Period may be extended for up to 30 days for reasons described in "Investigational Plan" above. Additionally, an extension of up to 90 days to the Screening Period will be permitted if a subject has met all eligibility criteria but randomization is temporarily unavailable due to DEEC dose escalation/dose expansion review.
|
Randomised Controlled | Double | [{"id":41928,"code":2,"name":"Investigator"},{"id":41929,"code":3,"name":"Monitor"},{"id":41926,"code":5,"name":"Carer"},{"id":41927,"code":1,"name":"Subject"},{"id":41925,"code":4,"name":"Analyst"}] | ABBV-916 Dose 1: ABBV-916 Dose 1, IV administration once every four weeks ABBV-916 Dose 2: ABBV-916 Dose 2, IV administration once every four weeks Placebo: Placebo, IV administration once every four weeks. |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Adult male or female, 50 to 90 years of age, inclusive, at time of consent.
- Subjects must have, in the investigator's opinion, adequate premorbid literacy, visual or auditory acuity to complete the required neuropsychological testing.
- Subjects will have an MMSE score of 20 to 28 (inclusive) at Screening, a blood-based biomarker result with a value consistent with amyloid PET positivity, and amyloid PET scan results consistent with amyloid pathology (as determined by visual assessment and a centiloid value of 37 or higher).
Exclusion criteria 6
- Subject must not have any elective surgery from 2 weeks prior to randomization or anticipated to be performed through the end of the study.
- Subject must not be currently enrolled in another clinical study or previously enrolled in this study.
- Subject's screening MRI must not show evidence of or significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the subject's ability to safely participate in the study.
- Subjects must not have hypersensitivity to mAb treatments, protein derived from a mAb, or immunoglobulin therapy.
- Subject must not have a history of drug or alcohol abuse within 2 years prior to study drug administration.
- Subject must not have known history of, or positive Screening test result for hepatitis C virus or hepatitis B virus, human immunodeficiency virus (HIV) or other immunodeficiencies.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary efficacy endpoint for Stage B is change from Baseline in brain amyloid plaque deposition (amyloid centiloid value) at Week 24 as measured by amyloid PET scan.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10176049 · Product
- Active substance
- Florquinitau (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 740 MBq megabecquerel(s)
- Max treatment duration
- 32 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10069929 · Product
- Active substance
- Humanised IGG1 Monoclonal Antibody Against N-Terminally Truncated PYROGLUTAMATE-3 Ab
- Substance synonyms
- ABBV-916, Humanised IgG1 monoclonal antibody against ABpE3
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 32 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- 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
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinial Trial Helpdesk
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
| WCG Clinical Inc. ORG-100040730
|
Fremont, United States | Other |
| C2N Diagnostics, LLC ORL-000000514
|
Saint Louis, United States | Laboratory analysis |
| Global Alzheimer’s Platform Foundation Inc ORL-000000517
|
Westport, United States | Other |
| Qd Solutions Inc. ORG-100041849
|
Austin, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Basel, Switzerland | Laboratory analysis |
| Cerveau Technologies Inc. ORG-100042727
|
Knoxville, United States | Other |
| Patient Advertising Guru Inc. ORG-100046268
|
Melville, United States | Other |
| Reify Health ORL-000000515
|
Boston, United States | Other |
Locations
3 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 34 | 8 |
| Portugal | Ended | 21 | 5 |
| Spain | Ended | 43 | 10 |
| Rest of world
Japan, Canada, United States
|
— | 86 | — |
Investigational sites
Azienda Ospealiero Universitaria Policlinico Umberto I
Neurology Department, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Neurology Department, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero Universitaria Di Modena
Neurology Department, Largo Del Pozzo 71, 41124, Modena
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology Department, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Neurology Department, Via Francesco Sforza 35, 20122, Milan
San Giovanni Calibita Fatebenefratelli Hospital
Neurology Department, Isola Tiberina 1, 00060, Rome
Ospedale San Raffaele S.r.l.
Neurology Department, Via Olgettina 60, 20132, Milan
Instituto Di Ricovero E Cura A Carattere Scientifico
Alzheimer rehabilitation department, Via Pilastroni 4, 25125, Brescia
CCAB Centro Clinico Academico Braga Associacao
Neurology Department, Lugar De Sete Fontes S Victor, 4710-243, Braga
Centro Hospitalar E Universitario De Coimbra E.P.E.
Neurology Department, Av Bissaya Barreto, 3000-075, Coimbra
CNS Saude Lda
Neurology Department, Bairro De Santo Antonio 47, 2560-280, Torres Vedras
Unidade Local De Saude De Matosinhos E.P.E.
Neurology Department, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Neurology Department, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Hospital Victoria Eugenia De La Cruz Roja Espanola
Neurology Department, Avenida La Cruz Roja 1, 41009, Sevilla
Hospital Universitari General De Catalunya
Neurology Department, Calle Pedro I Pons 1, 08195, Barcelona
Policlinica Gipuzkoa
Neurology Department, Paseo Miramon 174, 20009, Donostia
Hospital Universitario 12 De Octubre
Neurology Department, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Clinico San Carlos
Neurology Department, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
Hospital Universitario Quironsalud Madrid
Neurology Department, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Salamanca
Neurology Department, Paseo De San Vicente 58-182, 37007, Salamanca
Oroitu S.L.
Neurology Department, Bl C, Calle Jata 8, Algorta
Hospital Clinic De Barcelona
Neurology Department, Calle Villarroel 170, 08036, Barcelona
Fundacio Ace Institut Catala De Neurociencies Aplicades
Alzheimer Treatment & Research Center, Gran Via De Carles III 85 Bis, 08028, Barcelona
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-20 | Italy | Acceptable 2023-07-27
|
2023-07-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-14 | Italy | Acceptable 2023-07-27
|
2023-08-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-18 | Italy | Acceptable 2023-12-18
|
2023-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-28 | Italy | Acceptable 2024-05-09
|
2024-05-13 |