An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

NCT03712787 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: M15-5702018-000268-26
• Study Type: interventional
• Target: 364
• Locations: 10 countries
• Sites: 57

Brief Summary

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs

  Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.

  From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

• Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values

  Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

  Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

• Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values

  Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03

  Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

• Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period

  The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.

  Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

• Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease

  Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.

Study Arms (4)

300 mg/1000 mg Tilavonemab

EXPERIMENTAL

Participants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years.

Drug: Tilavonemab

1000 mg/1000 mg Tilavonemab

EXPERIMENTAL

Participants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Drug: Tilavonemab

2000 mg/2000 mg Tilavonemab

EXPERIMENTAL

Participants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Drug: Tilavonemab

PBO/2000 mg Tilavonemab

EXPERIMENTAL

Participants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years.

Drug: Tilavonemab

Interventions

Tilavonemab DRUG

solution for IV infusion

Also known as: ABBV-8E12

1000 mg/1000 mg Tilavonemab; 2000 mg/2000 mg Tilavonemab; 300 mg/1000 mg Tilavonemab; PBO/2000 mg Tilavonemab

Eligibility Criteria

• Age: 57 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subject was compliant during participation in Study M15-566 (NCT02880956)
• Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities
• The subject has any significant change in his/her medical condition since participation in Study M15-566 (NCT02880956) that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results
• More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566 (NCT02880956)
• The subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (57)

Banner University of Arizona Medical Center Phoenix /ID# 203959

Phoenix, Arizona, 85006, United States

Location

Irvine Clinical Research /ID# 204000

Irvine, California, 92614, United States

Location

Ucsd /Id# 204001

La Jolla, California, 92037, United States

Location

University of California, San /ID# 204011

San Francisco, California, 94143-0633, United States

Location

Brain Matters Research /ID# 203957

Delray Beach, Florida, 33445, United States

Location

Neuropsychiatric Research Center of Southwest Florida /ID# 203956

Fort Myers, Florida, 33912, United States

Location

Mayo Clinic /ID# 203995

Jacksonville, Florida, 32224, United States

Location

Synexus Clinical Research US, Inc. /ID# 203992

Orlando, Florida, 32806-1044, United States

Location

University of South Florida /ID# 204009

Tampa, Florida, 33612, United States

Location

Synexus Clinical Research US, Inc /ID# 204010

The Villages, Florida, 32162-7116, United States

Location

Emory University / Emory Brain Health Center /ID# 203999

Atlanta, Georgia, 30329-2206, United States

Location

NeuroStudies.net, LLC /ID# 204004

Decatur, Georgia, 30030, United States

Location

Advocate Lutheran General Hospital /ID# 203993

Park Ridge, Illinois, 60068, United States

Location

Southern IL Univ School of Med /ID# 203952

Springfield, Illinois, 62702, United States

Location

Indiana University /ID# 203989

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960

Fairway, Kansas, 66205, United States

Location

University of Kentucky Chandler Medical Center /ID# 203996

Lexington, Kentucky, 40536, United States

Location

Massachusetts General Hospital /ID# 203954

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Physicians /ID# 204003

Boston, Massachusetts, 02115, United States

Location

Hattiesburg Clinic /ID# 213435

Hattiesburg, Mississippi, 39401, United States

Location

Princeton Medical Institute /ID# 203953

Princeton, New Jersey, 08540, United States

Location

North Shore University Hospital /ID# 203994

New Hyde Park, New York, 11040, United States

Location

Duke Univ Med Ctr /ID# 203958

Durham, North Carolina, 27710, United States

Location

Oregon Health and Science University /ID# 203997

Portland, Oregon, 97239, United States

Location

Keystone Clinical Studies LLC /ID# 213183

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Rhode Island Hospital /ID# 204005

Providence, Rhode Island, 02903, United States

Location

Vanderbilt Ingram Cancer Center /ID# 203951

Nashville, Tennessee, 37232-0021, United States

Location

Kerwin Research Center /ID# 203998

Dallas, Texas, 75231-4316, United States

Location

Houston Methodist Hospital /ID# 204002

Houston, Texas, 77030, United States

Location

McGovern Medical School /ID# 213312

Houston, Texas, 77054, United States

Location

University of Utah /ID# 203991

Salt Lake City, Utah, 84112-5500, United States

Location

Integrated Neurology Services /ID# 203990

Alexandria, Virginia, 22310, United States

Location

St Vincent's Centre for Applied Medical Research /ID# 204903

Darlinghurst, New South Wales, 2010, Australia

Location

Griffith University /ID# 204905

Southport, Queensland, 4222, Australia

Location

Austin Health /ID# 204906

Heidelberg, Victoria, 3084, Australia

Location

Australian Alzheimer's Res Fou /ID# 204904

Nedlands, Western Australia, 6009, Australia

Location

UCL Saint-Luc /ID# 204963

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 204965

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Groupe Sante CHC - Clinique du MontLegia /ID# 204964

Liège, 4000, Belgium

Location

Parkwood Institute /ID# 204121

London, Ontario, N6C 0A7, Canada

Location

Toronto Memory Program /ID# 204120

Toronto, Ontario, M3B 2S7, Canada

Location

Rigshospitalet /ID# 204591

Copenhagen Ø, Capital Region, 2100, Denmark

Location

Clinical Research Services Turku /ID# 205924

Turku, Southwest Finland, 20520, Finland

Location

Ita-Suomen Yliopisto /ID# 204538

Kuopio, 70210, Finland

Location

AOU di Modena /ID# 203904

Modena, Emilia-Romagna, 41126, Italy

Location

Policlinico Agostino Gemelli /ID# 203906

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliera di Perugia /ID# 203905

Perugia, Umbria, 06129, Italy

Location

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903

Brescia, 25125, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902

Milan, 20122, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda /ID# 203901

Milan, 20162, Italy

Location

CGM Research Trust /ID# 204907

Burwood, 8083, New Zealand

Location

Fundacion CITA Alzheimer Fundazioa /ID# 204521

Donostia / San Sebastian, Basque Country, 20009, Spain

Location

Fundacio ACE /ID# 204520

Barcelona, 08028, Spain

Location

Hospital Clinic de Barcelona /ID# 204519

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre /ID# 204518

Madrid, 28041, Spain

Location

Karolinska University Hospital Huddinge /ID# 203900

Stockholm, Stockholm County, 171 77, Sweden

Location

Sahlgrenska University Hospital Molndal /ID# 203899

Mölndal, Västra Götaland County, 431 80, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tilavonemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Study M15-570 was discontinued because of lack of efficacy in the parent study (Study M15-566) and 2) the tilavonemab development program was discontinued.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: March 22, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

BE (3); ES (4); CA (2); NZ (1); SE (2); IT (6); US (32); AU (4); DK (1); FI (2)