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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: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) -> ABBV-599 High Dose - Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

Experimental: Elsubrutinib placebo/upadacitinib 30 mg -> Elsubrutinib placebo/upadacitinib 30 mg - Participants received placebo capsules for elsubrutinib once a day by mouth and upadacitinib 30 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

Experimental: Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 High Dose - Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 30 mg film-coated tablets once a day in the current study (M20-186) for up to 56 weeks.

Experimental: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) -> ABBV-599 Low Dose - Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

Experimental: Elsubrutinib 60 mg/upadacitinib placebo -> Elsubrutinib 60 mg/upadacitinib placebo - Participants received elsubrutinib 60 mg capsules once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants continued on this regimen in the current study (M20-186) for up to 56 weeks.

Experimental: Elsubrutinib placebo/upadacitinib placebo -> ABBV-599 Low Dose - Participants received placebo capsules for elsubrutinib once a day by mouth and placebo film-coated tablets for upadacitinib once a day by mouth for 48 weeks in Study M19-130. Participants received elsubrutinib 60 mg capsules once a day by mouth and upadacitinib 15 mg film-coated tablets once a day by mouth for 48 weeks in the current study (M20-186) for up to 56 weeks.


Treatment: Drugs: Elsubrutinib
Capsule; Oral

Treatment: Drugs: Placebo for Elsubrutinib
Capsule; Oral

Treatment: Drugs: Upadacitinib
Film-coated tablet; Oral

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [1] 0 0
From the first dose of study drug in Study M20-186 up to 30 days after the last dose of study drug, up to 442 days
Secondary outcome [1] 0 0
Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Timepoint [1] 0 0
Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Secondary outcome [2] 0 0
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response
Timepoint [2] 0 0
Baseline of Study M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Secondary outcome [3] 0 0
Change From Baseline in Daily Prednisone Dose Over Time
Timepoint [3] 0 0
Baseline of M19-130 (Week 0), Weeks 56, 64, 72, 80, 88, 96, 104
Secondary outcome [4] 0 0
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) Flare Index Through Week 104
Timepoint [4] 0 0
From Week 56 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
Guizhou
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
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
Valle Del Cauca
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 Teugbyeolsi
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
Keelung
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taipei
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taichung
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taipei City
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taoyuan City
Country [65] 0 0
United Kingdom
State/province [65] 0 0
London, City Of
Country [66] 0 0
United Kingdom
State/province [66] 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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04451772