Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Autonoma De Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Argentina
State/province [19] 0 0
Tucuman
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Guangdong
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
China
State/province [24] 0 0
Urumqi
Country [25] 0 0
Colombia
State/province [25] 0 0
Atlantico
Country [26] 0 0
Colombia
State/province [26] 0 0
Cundinamarca
Country [27] 0 0
Colombia
State/province [27] 0 0
Medellin
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Dresden
Country [30] 0 0
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
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Hiroshima
Country [36] 0 0
Japan
State/province [36] 0 0
Hokkaido
Country [37] 0 0
Japan
State/province [37] 0 0
Kagoshima
Country [38] 0 0
Japan
State/province [38] 0 0
Miyagi
Country [39] 0 0
Japan
State/province [39] 0 0
Nagano
Country [40] 0 0
Japan
State/province [40] 0 0
Saitama
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Mexico
State/province [43] 0 0
Ciudad De Mexico
Country [44] 0 0
Mexico
State/province [44] 0 0
Guanajuato
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Yucatan
Country [47] 0 0
New Zealand
State/province [47] 0 0
Auckland
Country [48] 0 0
Poland
State/province [48] 0 0
Dolnoslaskie
Country [49] 0 0
Poland
State/province [49] 0 0
Malopolskie
Country [50] 0 0
Poland
State/province [50] 0 0
Mazowieckie
Country [51] 0 0
Poland
State/province [51] 0 0
Wielkopolskie
Country [52] 0 0
Puerto Rico
State/province [52] 0 0
San Juan
Country [53] 0 0
Spain
State/province [53] 0 0
Alava
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Vizcaya
Country [56] 0 0
Spain
State/province [56] 0 0
A Coruna
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Sevilla
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Taiwan
State/province [60] 0 0
Taichung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taipei City
Country [62] 0 0
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
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/ct2/show/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