A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Elsubrutinib; Drug: Placebo for elsubrutinib; Drug: Upadacitinib; Drug: Placebo for upadacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03823378

2018-002306-31 (EudraCT Number)

M16-763

Details and patient eligibility

About

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).

Full description

This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib [ELS] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib [UPA] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has completed Study M16-063
• Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol
• Participant is willing and/or able to comply with procedures required in the current study protocol

Exclusion criteria

• Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063)
• Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 6 patient groups

ABBV-599 in M16-063/ABBV-599 in M16-763

Experimental group

Description:

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks

Treatment:

Drug: Upadacitinib

Drug: Elsubrutinib

ABBV-105 60 mg/UPA placebo

Experimental group

Description:

60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Treatment:

Drug: Placebo for upadacitinib

Drug: Elsubrutinib

ABBV-105 20 mg/UPA placebo

Experimental group

Description:

20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Treatment:

Drug: Placebo for upadacitinib

Drug: Elsubrutinib

ABBV-105 5 mg/UPA placebo

Experimental group

Description:

5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks

Treatment:

Drug: Placebo for upadacitinib

Drug: Elsubrutinib

UPA 15 mg/ABBV-105 placebo

Experimental group

Description:

15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks

Treatment:

Drug: Placebo for elsubrutinib

Drug: Upadacitinib

Placebo in M16-063/ABBV-599 in M16-763

Experimental group

Description:

Placebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763

Treatment:

Drug: Upadacitinib

Drug: Elsubrutinib