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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
Date last updated
18/11/2024

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
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383.

ABBV-383 is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses. After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 20 sites across the world.

Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT06158854
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06158854