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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
Date last updated
25/01/2024

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
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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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New York
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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
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Argentina
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Tucuman
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Bulgaria
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Sofia
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China
State/province [21] 0 0
Beijing
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China
State/province [22] 0 0
Guangdong
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China
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Shanghai
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China
State/province [24] 0 0
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
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Berlin
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Germany
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Dresden
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Hungary
State/province [30] 0 0
Hajdu-Bihar
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Hungary
State/province [31] 0 0
Veszprem
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Italy
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Ferrara
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Japan
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Aichi
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Japan
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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
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Japan
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Saitama
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Japan
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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
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Poland
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Wielkopolskie
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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
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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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
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms.

ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 100 sites worldwide.

Participants will receive the following for up to 56 weeks:

Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study.

Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B

There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of 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 completing questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT04451772
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04451772