Phase 2
Completed N=242
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
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT03682705 ↗
Enrolled (actual)
242
Serious AEs
2.5%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 — -1.12; -2.56; -1.52; -1.32 units on a scale — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 |
-1.12; -2.56; -1.52; -1.32; -1.33; -2.87 | <0.001 sig |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) |
-6.08; -16.00; -8.95; -7.36; -8.38; -14.03 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) |
-6.17; -17.01; -8.79; -7.42; -8.54; -15.30 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 |
10.5; 32.3; 19.5; 7.7; 9.8; 42.5 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) at Week 12 |
21.1; 41.9; 22.0; 10.3; 14.6; 55.0 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria |
10.5; 16.1; 9.8; 0; 2.4; 12.5 | — |
| SECONDARY Percentage of Participants Achieving Complete Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria |
0; 3.2; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response |
21.1; 45.2; 24.4; 12.8; 14.6; 52.5 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response |
0; 16.1; 4.9; 0; 0; 12.5 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response |
0; 8.1; 2.4; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Tender Joint Count 68 (TJC68) |
-2.47; -8.42; -3.65; -3.86; -4.88; -8.57 | — |
| SECONDARY Change From Baseline in Swollen Joint Count 66 (SJC66) |
-3.12; -6.06; -3.61; -3.30; -4.13; -6.02 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Pain (Visual Analog Scale [VAS]) |
-14.97; -24.02; -10.22; -8.78; -7.61; -15.99 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity (PGA) |
-11.87; -23.44; -11.16; -6.47; -5.95; -14.76 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity (PhGA) |
-16.31; -22.35; -19.01; -16.12; -11.64; -24.71 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.22; -0.34; -0.13; -0.06; -0.16; -0.22 | — |
| SECONDARY Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP) |
-0.51; -9.29; 2.26; -0.34; -0.72; -12.27 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) |
-0.46; -1.53; -0.63; -0.44; -0.56; -1.43 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28- ESR) |
-0.46; -1.48; -0.52; -0.46; -0.57; -1.32 | — |
| SECONDARY Change From Baseline in Morning Stiffness Severity |
-1.76; -2.02; -0.91; -0.68; -0.59; -1.84 | — |
| SECONDARY Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) |
52.6; 51.6; 36.6; 30.8; 36.6; 52.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (EULAR) Boolean Remission |
0; 1.6; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
- Participant meets the following minimum disease activity criteria:
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
- High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening Visit
- Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration
- Participants must have been receiving conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug
- Participants must have discontinued all bDMARDs prior to the first dose of study drug
Exclusion Criteria
- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2 weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT03682705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.