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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04451772




Registration number
NCT04451772
Ethics application status
Date submitted
29/06/2020
Date registered
30/06/2020

Titles & IDs
Public title
A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State
Scientific title
A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
Secondary ID [1] 0 0
2020-001690-72
Secondary ID [2] 0 0
M20-186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE) 0 0
Condition category
Condition code
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 - Elsubrutinib
Treatment: Drugs - Placebo for Elsubrutinib
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib

Experimental: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A - Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).

Experimental: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B - Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.

Experimental: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo - Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.

Experimental: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A - Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.


Treatment: Drugs: Elsubrutinib
Oral; Capsule

Treatment: Drugs: Placebo for Elsubrutinib
Oral; Capsule

Treatment: Drugs: Upadacitinib
Oral; Tablet

Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
Through Week 108
Secondary outcome [1] 0 0
Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Timepoint [1] 0 0
Through Week 104
Secondary outcome [2] 0 0
Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)
Timepoint [2] 0 0
Through Week 104
Secondary outcome [3] 0 0
Change in Steroid Burden
Timepoint [3] 0 0
Baseline of M19-130 (Week 0) Through Week 104
Secondary outcome [4] 0 0
Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)
Timepoint [4] 0 0
Through Week 104

Eligibility
Key inclusion criteria
* Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
* On stable background treatment for SLE throughout the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active, chronic, or recurrent viral, or bacterial infection.
* Active tuberculosis (TB)
* History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
* Participant require vaccination with live vaccine during study participation.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/01/2024
Sample size
Target
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit Sunshine Coast /ID# 221816 - Maroochydore
Recruitment hospital [2] 0 0
Emeritus Research /ID# 223027 - Camberwell
Recruitment hospital [3] 0 0
Monash Medical Centre /ID# 221814 - Clayton
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma De Buenos Aires
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Argentina
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Santa Fe
Country [19] 0 0
Argentina
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Tucuman
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Bulgaria
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Sofia
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China
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Beijing
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China
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Guangdong
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China
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Shanghai
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China
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Urumqi
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Colombia
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Atlantico
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Colombia
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Cundinamarca
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Colombia
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Medellin
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Germany
State/province [28] 0 0
Berlin
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Germany
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Dresden
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Hungary
State/province [30] 0 0
Hajdu-Bihar
Country [31] 0 0
Hungary
State/province [31] 0 0
Veszprem
Country [32] 0 0
Italy
State/province [32] 0 0
Ferrara
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi
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Japan
State/province [34] 0 0
Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Kagoshima
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Japan
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Miyagi
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Japan
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Nagano
Country [40] 0 0
Japan
State/province [40] 0 0
Saitama
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Japan
State/province [41] 0 0
Tokyo
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Korea, Republic of
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Seoul
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Mexico
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Ciudad De Mexico
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Yucatan
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New Zealand
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Auckland
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Poland
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Dolnoslaskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
Country [51] 0 0
Poland
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Wielkopolskie
Country [52] 0 0
Puerto Rico
State/province [52] 0 0
San Juan
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Spain
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Alava
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Spain
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Barcelona
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Spain
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Vizcaya
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Spain
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A Coruna
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Spain
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Madrid
Country [58] 0 0
Spain
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Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taichung
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Taiwan
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Taipei City
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Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taoyuan City
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London, City Of
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Manchester

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


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/NCT04451772