A Phase 2 interventional study of ABBV-722 and Upadacitinib in Rheumatoid Arthritis, sponsored by AbbVie. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function. Synovial fibroblasts play a key role in RA pathogenesis, with treatment-refractory patients demonstrating increased numbers of these cells. The goal of this study is to evaluate the safety and effectiveness of ABBV-2294 (a combination of ABBV-722 and upadacitinib) compared to each drug alone in treating moderately to severely active RA. The platform study will measure improvements in disease activity using the American College of Rheumatology (ACR) criteria, changes in disease activity scores, and quality of life measures.
ABBV-2294 is an investigational combination drug being developed for the treatment of moderately to severely active rheumatoid arthritis. This is a Phase 2b, randomized, double-blind platform study. In sub-study 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment consisting of either ABBV-722 alone, upadacitinib alone, or various doses of ABBV-722 combined with upadacitinib. Adult participants with a diagnosis of moderately to severely active rheumatoid arthritis who have failed at least 1 prior biologic disease-modifying antirheumatic drug (bDMARD) will be enrolled. Around 250 participants will be enrolled in the study at multiple sites worldwide.
Participants will receive oral tablet doses of ABBV-2294 (combination of ABBV-722 and upadacitinib), ABBV-722 alone, or upadacitinib alone. The study comprises a 24-week Double-Blind Phase (Period 1) followed by an optional 52-week Blinded Long Term Extension Phase (Period 2), for a total treatment duration of up to 76 weeks. After completing treatment, participants will have a 30-day Follow-Up Period.
Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits through Week 76, followed by a follow-up visit. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 250 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive co-administration of ABBV-722 and upadacitinib
Drug: ABBV-722 · Drug: Upadacitinib
Participants will receive co-administration of ABBV-722 and upadacitinib
Drug: ABBV-722 · Drug: Upadacitinib
Participants will receive co-administration of ABBV-722 and upadacitinib
Drug: ABBV-722 · Drug: Upadacitinib
Participants will receive ABBV-722. At Week 12, participants will then be blindly switched to co-administration of ABBV-722 and upadacitinib.
Drug: ABBV-722
Participants will receive upadacitinib.
Drug: Upadacitinib
Oral Tablet
Oral Tablet
Percentage of Participants Achieving ACR50 Response
The ACR50 response is defined as at least 50% improvement in the American College of Rheumatology (ACR) criteria for rheumatoid arthritis. The ACR50 response requires at least 50% improvement in tender and swollen joint counts and at least 50% improvement in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function (HAQ-DI), and acute phase reactant (CRP or ESR).
Time frame: Week 12
Number of Participants Experiencing Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 80 Weeks
Percentage of Participants Achieving ACR20 Response
ACR20 response is defined as at least 20% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Time frame: Week 12
Percentage of Participants Achieving ACR70 Response
ACR70 response is defined as at least 70% improvement from Baseline in the American College of Rheumatology (ACR) core criteria, which includes tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, and acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
Time frame: Week 12
Percentage of Participants Achieving Low Disease Activity Based on DAS28 (CRP) <= 3.2
Low Disease Activity (LDA) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 \[CRP\]) of \<= 3.2. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity.
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) < 2.6
Clinical Remission (CR) is defined as a Disease Activity Score 28 using C-reactive protein (DAS28 \[CRP\]) of \< 2.6. DAS28 (CRP) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity.
Time frame: Week 12
Percentage of Participants with a Change From Baseline in DAS28 (CRP)
Disease Activity Score 28 using C-reactive protein (DAS28 \[CRP\]) is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and C-reactive protein. Scores range from 0 to approximately 10, with higher scores indicating more disease activity. A negative change from Baseline indicates improvement.
Time frame: Baseline to Week 12
Percentage of Participants Achieving Low Disease Activity Based on Clinical Disease Activity Index (CDAI) <= 10
Low Disease Activity (LDA) is defined as a Clinical Disease Activity Index (CDAI) of \<= 10. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity.
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission Based on CDAI <= 2.8
Clinical Remission (CR) is defined as a Clinical Disease Activity Index (CDAI) of \<= 2.8. CDAI is a composite score derived from tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and physician's global assessment of disease activity. Scores range from 0 to 76, with higher scores indicating more disease activity.
Time frame: Week 12
No study locations are listed for this record.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jul 2029, 31 months later.
Of 116 industry-sponsored phase 2 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 24. This study's planned 31 months is above that.
Counting every sponsor, half of 158 studies reached it within 18 months; a quarter within 13 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: ABBV-722 · Upadacitinib