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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06158854




Registration number
NCT06158854
Ethics application status
Date submitted
28/11/2023
Date registered
6/12/2023

Titles & IDs
Public title
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving ABBV-383 as an Intravenous (IV) Infusion
Scientific title
An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis
Secondary ID [1] 0 0
2023-503429-20-00
Secondary ID [2] 0 0
M24-209
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin Light Chain (AL) Amyloidosis 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-383

Experimental: Dose Escalation: ABBV-383 Dose A - Participants will receive ABBV-383 dose A during the approximately 2 year study duration.

Experimental: Dose Escalation: ABBV-383 Dose B - Participants will receive ABBV-383 dose B during the approximately 2 year study duration.

Experimental: Dose Escalation: ABBV-383 Dose C - Participants will receive ABBV-383 dose C during the approximately 2 year study duration.

Experimental: Safety Expansion: ABBV-383 Expansion A - Participants will receive ABBV-383 expansion dose A during the approximately 2 year study duration.

Experimental: Safety Expansion: ABBV-383 Expansion B - Participants will receive ABBV-383 expansion dose B during the approximately 2 year study duration.


Treatment: Drugs: ABBV-383
Intravenous Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose-Limiting Toxicities (DLT)
Timepoint [1] 0 0
Up to 28 Days
Secondary outcome [1] 0 0
Percentage of Participants who Achieve Hematologic Complete Response (CR)
Timepoint [1] 0 0
Up to 3 Years
Secondary outcome [2] 0 0
Overall Hematologic Response (OHR)
Timepoint [2] 0 0
Up to 3 Years
Secondary outcome [3] 0 0
Time to Hematologic CR
Timepoint [3] 0 0
Up to 3 Years
Secondary outcome [4] 0 0
Duration of Hematologic CR
Timepoint [4] 0 0
Up to 3 Years
Secondary outcome [5] 0 0
Organ Response Rate (OrRR)
Timepoint [5] 0 0
Up to 3 Years
Secondary outcome [6] 0 0
Time to Organ Response
Timepoint [6] 0 0
Up to 3 Years

Eligibility
Key inclusion criteria
* Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis.
* Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
* Have at least 1 organ historically impacted by AL amyloidosis.
* Considered AL amyloidosis risk stage 1, 2, or 3a and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L.
* Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
* Known allergic reaction, significant sensitivity, or intolerance to constituents of the study drugs (and excipients) and/or other products in the same class.
* Participant has the following conditions:

* Other non-AL amyloid disease;
* Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium > 11 mg/dL);
* Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential);
* Waldenström's macroglobulinemia;
* Acute diffuse infiltrative pneumopathy;
* Major surgery within 28 days prior first dose or planned during study participation;
* History of organ transplant requiring continued use of immunosuppressants;
* Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral);
* Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study drug treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/02/2028
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital /ID# 255200 - Westmead
Recruitment hospital [2] 0 0
Princess Alexandra Hospital /ID# 255202 - Woolloongabba
Recruitment hospital [3] 0 0
Box Hill Hospital /ID# 255199 - Box Hill
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
France
State/province [6] 0 0
Franche-Comte
Country [7] 0 0
France
State/province [7] 0 0
Haute-Garonne
Country [8] 0 0
Greece
State/province [8] 0 0
Attiki
Country [9] 0 0
Italy
State/province [9] 0 0
Emilia-Romagna
Country [10] 0 0
Japan
State/province [10] 0 0
Aichi
Country [11] 0 0
Japan
State/province [11] 0 0
Kumamoto
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06158854