Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/study/NCT03978520




Registration number
NCT03978520
Ethics application status
Date submitted
3/06/2019
Date registered
7/06/2019

Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Scientific title
A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
2019-000638-20
Secondary ID [2] 0 0
M19-130
Universal Trial Number (UTN)
Trial acronym
SLEek
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

Placebo comparator: Elsubrutinib placebo/upadacitinib placebo - Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks

Experimental: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) - 60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks

Experimental: Elsubrutinib placebo/upadacitinib 30 mg - Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks

Experimental: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) - 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks

Experimental: Elsubrutinib 60 mg/upadacitinib placebo - 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 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
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose = 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change From Baseline in Daily Prednisone Dose at Week 24
Timepoint [4] 0 0
From Baseline to Week 24
Secondary outcome [5] 0 0
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Timepoint [5] 0 0
From Baseline to Week 24

Eligibility
Key inclusion criteria
* Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
* At Screening, must have at least one of the following:

* antinuclear antibody (ANA)+ (titer = 1:80)
* anti-dsDNA+
* anti-Smith+
* SLEDAI-2K (SLE Disease Activity Index) = 6 despite background therapy as reported and independently adjudicated (clinical score = 4, excluding lupus headache and/or organic brain syndrome) at Screening:

* If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
* If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
* Score must be re-confirmed at the Baseline visit.
* Physician's Global Assessment (PhGA) = 1 during screening period.
* Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (= 20 mg), azathioprine (= 150 mg), mycophenolate (<2 g), leflunomide (= 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (= 20 mg).

* No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

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
25/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/07/2022
Sample size
Target
Accrual to date
Final
341
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 222983 - Botany
Recruitment hospital [2] 0 0
Royal North Shore Hospital /ID# 222982 - St Leonards
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital /ID# 212667 - Herston
Recruitment hospital [4] 0 0
Rheumatology Research Unit Sunshine Coast /ID# 211902 - Maroochydore
Recruitment hospital [5] 0 0
Griffith University /ID# 223543 - Southport
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital /ID# 211901 - Woodville South
Recruitment hospital [7] 0 0
Emeritus Research /ID# 211903 - Camberwell
Recruitment hospital [8] 0 0
Monash Medical Centre /ID# 212313 - Clayton
Recruitment hospital [9] 0 0
St Vincent's Hospital Melbourne /ID# 212311 - Fitzroy Melbourne
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment postcode(s) [5] 0 0
4222 - Southport
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy Melbourne
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciuadad Autonoma De Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Tucuman
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
China
State/province [33] 0 0
Anhui
Country [34] 0 0
China
State/province [34] 0 0
Beijing
Country [35] 0 0
China
State/province [35] 0 0
Guangdong
Country [36] 0 0
China
State/province [36] 0 0
Hunan
Country [37] 0 0
China
State/province [37] 0 0
Jiangsu
Country [38] 0 0
China
State/province [38] 0 0
Shanghai
Country [39] 0 0
China
State/province [39] 0 0
Urumqi
Country [40] 0 0
Colombia
State/province [40] 0 0
Atlantico
Country [41] 0 0
Colombia
State/province [41] 0 0
Cundinamarca
Country [42] 0 0
Colombia
State/province [42] 0 0
Medellin
Country [43] 0 0
France
State/province [43] 0 0
Hauts-de-France
Country [44] 0 0
France
State/province [44] 0 0
Bordeaux
Country [45] 0 0
France
State/province [45] 0 0
Le Kremlin Bicetre
Country [46] 0 0
France
State/province [46] 0 0
Paris
Country [47] 0 0
France
State/province [47] 0 0
Strasbourg cedex
Country [48] 0 0
Germany
State/province [48] 0 0
Nordrhein-Westfalen
Country [49] 0 0
Germany
State/province [49] 0 0
Schleswig-Holstein
Country [50] 0 0
Germany
State/province [50] 0 0
Berlin
Country [51] 0 0
Germany
State/province [51] 0 0
Dresden
Country [52] 0 0
Hungary
State/province [52] 0 0
Hajdu-Bihar
Country [53] 0 0
Hungary
State/province [53] 0 0
Veszprem
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Hungary
State/province [55] 0 0
Gyula
Country [56] 0 0
Italy
State/province [56] 0 0
Ferrara
Country [57] 0 0
Italy
State/province [57] 0 0
Lazio
Country [58] 0 0
Italy
State/province [58] 0 0
Milan
Country [59] 0 0
Italy
State/province [59] 0 0
Udine
Country [60] 0 0
Japan
State/province [60] 0 0
Aichi
Country [61] 0 0
Japan
State/province [61] 0 0
Fukuoka
Country [62] 0 0
Japan
State/province [62] 0 0
Fukushima
Country [63] 0 0
Japan
State/province [63] 0 0
Hiroshima
Country [64] 0 0
Japan
State/province [64] 0 0
Hokkaido
Country [65] 0 0
Japan
State/province [65] 0 0
Hyogo
Country [66] 0 0
Japan
State/province [66] 0 0
Kagoshima
Country [67] 0 0
Japan
State/province [67] 0 0
Kanagawa
Country [68] 0 0
Japan
State/province [68] 0 0
Kumamoto
Country [69] 0 0
Japan
State/province [69] 0 0
Miyagi
Country [70] 0 0
Japan
State/province [70] 0 0
Nagano
Country [71] 0 0
Japan
State/province [71] 0 0
Saitama
Country [72] 0 0
Japan
State/province [72] 0 0
Tokyo
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Gyeonggido
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Seoul Teugbyeolsi
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Gwangju
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Incheon
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
Ciudad De Mexico
Country [79] 0 0
Mexico
State/province [79] 0 0
Guanajuato
Country [80] 0 0
Mexico
State/province [80] 0 0
Jalisco
Country [81] 0 0
Mexico
State/province [81] 0 0
San Luis Potosi
Country [82] 0 0
Mexico
State/province [82] 0 0
Yucatan
Country [83] 0 0
Netherlands
State/province [83] 0 0
Amsterdam
Country [84] 0 0
Netherlands
State/province [84] 0 0
Leiden
Country [85] 0 0
Netherlands
State/province [85] 0 0
Utrecht
Country [86] 0 0
New Zealand
State/province [86] 0 0
Auckland
Country [87] 0 0
New Zealand
State/province [87] 0 0
Waikato
Country [88] 0 0
Poland
State/province [88] 0 0
Dolnoslaskie
Country [89] 0 0
Poland
State/province [89] 0 0
Malopolskie
Country [90] 0 0
Poland
State/province [90] 0 0
Mazowieckie
Country [91] 0 0
Poland
State/province [91] 0 0
Wielkopolskie
Country [92] 0 0
Puerto Rico
State/province [92] 0 0
San Juan
Country [93] 0 0
Spain
State/province [93] 0 0
Alava
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Vizcaya
Country [96] 0 0
Spain
State/province [96] 0 0
A Coruna
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Sevilla
Country [99] 0 0
Spain
State/province [99] 0 0
Valencia
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taichung City
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taichung
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taipei City
Country [103] 0 0
Taiwan
State/province [103] 0 0
Taoyuan City
Country [104] 0 0
United Kingdom
State/province [104] 0 0
London, City Of
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Cambridge
Country [106] 0 0
United Kingdom
State/province [106] 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03978520