CLINICAL TRIALS PROFILE FOR ELSUBRUTINIB

Clinical Trials for Elsubrutinib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03682705 ↗	A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis	Completed	AbbVie	Phase 2	This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib [UPA]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
NCT03823378 ↗	A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib	Terminated	AbbVie	Phase 2	This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib [ELS]) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
NCT03978520 ↗	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)	Active, not recruiting	AbbVie	Phase 2	The main objective of this study is to evaluate the safety and efficacy of elsubrutinib, upadacitinib, and ABBV-599 vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
NCT04451772 ↗	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	Enrolling by invitation	AbbVie	Phase 2	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 146 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.

Clinical Trial Conditions for Elsubrutinib

Condition Name

Condition Name
Intervention	Trials
Rheumatoid Arthritis (RA)	2
Systemic Lupus Erythematosus (SLE)	2

Condition MeSH

Condition MeSH
Intervention	Trials
Lupus Erythematosus, Systemic	2
Arthritis, Rheumatoid	2
Arthritis	2

Clinical Trial Locations for Elsubrutinib

Trials by Country

Trials by Country
Location	Trials
United States	64
Spain	18
Japan	17
Poland	16
Mexico	12

Trials by US State

Trials by US State
Location	Trials
Tennessee	3
Ohio	3
Michigan	3
Massachusetts	3
Illinois	3

Clinical Trial Progress for Elsubrutinib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	4

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Enrolling by invitation	1
Terminated	1
Active, not recruiting	1

Clinical Trial Sponsors for Elsubrutinib

Sponsor Name

Sponsor Name
Sponsor	Trials
AbbVie	4

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	4