A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.

• Register: EUCTR
• Last refreshed on: 10 June 2024
• Main ID: EUCTR2020-001690-72-DE
• Date of registration: 15/01/2021
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.
• 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) - A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE
• Date of first enrolment: 02/03/2021
• Target sample size: 260
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001690-72
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: EU clinical trials helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU clinical trials helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects will have completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV599 [elsubrutinib/upadacitinib] combination)
2. Subjects must be on stable background treatment for SLE throughout the study.
3. Subjects must understand and voluntarily sign and date an IEC/IRB- approved informed consent
4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test
5. Female subjects must be either postmenopausal, OR permanently surgically sterile OR practicing at least one protocol-specified method of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion criteria:
1. Subjects may not have any active, chronic, or recurrent viral or bacterial infection.
2. Must not require vaccination with any live vaccine during study participation.
3. Must not have a history of any malignancy except for successfully treated Non-Melanoma Skin Cancer (NMSC) or localized carcinoma in-situ (CIS) of the cervix.
4. Must not be a recipient of an organ transplant.
5. Women must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for at least 30 days after the last dose of study drug.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Immune system processes [G12]

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Elsubrutinib
Product Code: ABBV-105
Pharmaceutical Form: Capsule
INN or Proposed INN: Elsubrutinib
CAS Number: 1643570-24-4
Current Sponsor code: ABBV-105
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: UPADACITINIB
CAS Number: 2050057-56-0
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: UPADACITINIB
CAS Number: 2050057-56-0
Current Sponsor code: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

Secondary Objective: To obtain longer-term efficacy data beyond Week 48 with the treatments studied in the RCT (monotherapies and combination) to more fully assess the benefit /risk of each treatment over time.

Primary end point(s): Not applicable.

Timepoint(s) of evaluation of this end point: Not applicable.

Secondary Outcome(s)

Secondary end point(s): • Achievement of SLE Responder Index (SRI)-4.
• Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) response.
• Steroid burden, assessed as change from M19-130 Baseline.
• Number of mild, moderate or severe flares per patient-year (respectively and overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index (SFI), assessed by number and types of flare per subject.

Timepoint(s) of evaluation of this end point: All visits.

Secondary ID(s)

2020-001690-72-NL

M20-186

Source(s) of Monetary Support

AbbVie Inc

Ethics review

Status: Approved
Approval date: 02/03/2021
Contact: