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Rheumatoid ArthritisPhase 2NCT07904754

Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis

A Phase 2 study testing ABBV-722 and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
ABBV-722 and Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
7 Dec 2026to Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented clinical diagnosis of RA for >= 3 months and fulfills 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for Rheumatoid arthritis
  • No clinically significant medical conditions that would interfere with study participation or compromise participant safety
  • Willing and able to comply with procedures required in this Master Protocol and all actively enrolling substudies
  • Female participants who are not pregnant or breastfeeding, with negative pregnancy tests at Screening and Baseline

Who cannot join

  • Development of a major cardiovascular event (e.g., acute myocardial infarction, stroke) while on study treatment
  • Serious infection (e.g., sepsis) which cannot be adequately controlled by anti-infective treatment
  • Confirmed diagnosis of deep vein thrombosis, pulmonary embolus or arterial thrombosis
  • Development of active tuberculosis at any time during the study
  • Development of any malignancy except localized non-melanoma skin cancer or carcinoma in situ of the cervix

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

About this study

Official title: A Phase 2b, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

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.

Read more

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.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. 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.

Being tested
ABBV-722, Upadacitinib
Keywords
Rheumatoid Arthritis, ABBV-722, Upadacitinib, ABBV-2294
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-722Drug

    Oral Tablet

  • UpadacitinibDrug

    Oral Tablet

Study groups in NCT07904754
Study groupRoleWhat they receive
ABBV-2294 Dose AExperimentalParticipants will receive co-administration of ABBV-722 and upadacitinib
Receives: Drug: ABBV-722; Drug: Upadacitinib
ABBV-2294 Dose BExperimentalParticipants will receive co-administration of ABBV-722 and upadacitinib
Receives: Drug: ABBV-722; Drug: Upadacitinib
ABBV-2294 Dose CExperimentalParticipants will receive co-administration of ABBV-722 and upadacitinib
Receives: Drug: ABBV-722; Drug: Upadacitinib
ABBV-722 MonotherapyExperimentalParticipants will receive ABBV-722. At Week 12, participants will then be blindly switched to co-administration of ABBV-722 and upadacitinib.
Receives: Drug: ABBV-722
Upadacitinib MonotherapyActive comparatorParticipants will receive upadacitinib.
Receives: Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 12

  2. 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.

    Measured: Up to 80 Weeks

Secondary outcomes (7)

  1. 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).

    Measured: Week 12

  2. 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).

    Measured: Week 12

  3. 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.

    Measured: Week 12

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Baseline to Week 12

  6. 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.

    Measured: Week 12

  7. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start7 Dec 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904754
Sponsor's protocol ID
M26-032
Other IDs
2026-526301-15-00
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-722 and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving ACR50 Response (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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