Rheumatoid ArthritisPhase 2NCT06972446
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
A Phase 2 study testing Lutikizumab and Ravagalimab in people with Rheumatoid Arthritis, run by AbbVie at 96 sites in 12 countries.
Trial summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). 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?
- Lutikizumab and Ravagalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 96 sitesin 12 countries
- Study dates
- 20 Jun 2025to Nov 2027
- 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
- At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
- Participant must be on a stable dose of methotrexate (MTX)
Who cannot join
- Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
Trial locations and contacts
96 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
96 sites in 12 countries
United States49 sites, 49 recruiting
- Recruiting
Albuquerque Center For Rheumatology /ID# 272301
Albuquerque, New Mexico, 87102
- Recruiting
Tekton Research - West Gate /ID# 272270
Austin, Texas, 78745
- Recruiting
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298
Avon Park, Florida, 33825
- Recruiting
Private Practice - Dr. David S. Hallegua /ID# 277608
Beverly Hills, California, 90211
- Recruiting
Trinity Universal Research Associates - Carrollton /ID# 272577
Carrollton, Texas, 75007
- Recruiting
Joint And Muscle Research Institute /ID# 277290
Charlotte, North Carolina, 28204
- Recruiting
DJL Clinical Research - Charlotte /ID# 272387
Charlotte, North Carolina, 28211-1064
- Recruiting
Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422
Chicago, Illinois, 60611
- Recruiting
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826
Chula Vista, California, 91910
Site Coordinator, 619-334-4735
- Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 272428
Clearwater, Florida, 33765
- Recruiting
Arthritis Care Of Texas /ID# 277961
Corpus Christi, Texas, 78415
Site Coordinator, 713-487-8680
- Recruiting
Altoona Center For Clinical Research /ID# 272479
Duncansville, Pennsylvania, 16635
Site Coordinator, 814-693-0300
- Recruiting
Tekton Research - Fort Collins - East Harmony Road /ID# 272472
Fort Collins, Colorado, 80528
- Recruiting
Arthritis and Rheumatology Research Institute - Frisco /ID# 272299
Frisco, Texas, 75035
- Recruiting
AA Medical Research Center - Grand Blanc /ID# 272496
Grand Blanc, Michigan, 48439
- Recruiting
Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621
Great Neck, New York, 11021
- Recruiting
Finlay Medical Research - Greenacres /ID# 281654
Greenacres City, Florida, 33467
- Recruiting
Neoclinical Research - Hialeah /ID# 272070
Hialeah, Florida, 33016
- Recruiting
South Florida Rheumatology /ID# 278339
Hollywood, Florida, 33026
- Recruiting
Accurate Clinical Research - Houston /ID# 272271
Houston, Texas, 77089-6142
- Recruiting
Private Practice - Dr. Laila A. Hassan /ID# 272297
Houston, Texas, 77089
- Recruiting
Care & Cure Clinic /ID# 281684
Houston, Texas, 77909
Site Coordinator, 832-234-1023
- Recruiting
Newport Huntington Medical Group /ID# 272439
Huntington Beach, California, 92648-5994
- Recruiting
West Tennessee Research Institute /ID# 272453
Jackson, Tennessee, 38305
- Recruiting
Swati Shah, MD Rheumatology /ID# 273624
Jacksonville, Florida, 32257
- Recruiting
Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896
Jonesboro, Arkansas, 72401
- Recruiting
Biopharma Informatic /ID# 279189
Katy, Texas, 77494
- Recruiting
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650
Lake Charles, Louisiana, 70605
- Recruiting
Deerbrook Medical Associates /ID# 273439
Libertyville, Illinois, 60048
- Recruiting
Life Clinical Trials - Colonial Drive - Margate /ID# 272589
Margate, Florida, 33063
- Recruiting
Southwest Rheumatology Research /ID# 272268
Mesquite, Texas, 75150
Site Coordinator, 972-288-2600
- Recruiting
Paramount Medical Research and Consulting /ID# 272474
Middleburg Heights, Ohio, 44130
- Recruiting
Advanced Quality Medical Research /ID# 277824
Orland Park, Illinois, 60462
- Recruiting
HMD Research LLC /ID# 272432
Orlando, Florida, 32819
- Recruiting
Vitalia Research /ID# 272478
Palm Beach Gardens, Florida, 33410
- Recruiting
Sun Valley Arthritis Center /ID# 278331
Peoria, Arizona, 85381
- Recruiting
Texas Rheumatology Research Institute /ID# 278010
Plano, Texas, 75024
- Recruiting
Epic Medical Research /ID# 272656
Red Oak, Texas, 75154
- Recruiting
Arnold Arthritis & Rheumatology /ID# 278354
Skokie, Illinois, 60076
- Recruiting
Fort Bend Rheumatology Associates /ID# 280761
Sugar Land, Texas, 77479
- Recruiting
Low Country Rheumatology /ID# 277607
Summerville, South Carolina, 29486
- Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
Tampa, Florida, 33606
Site Coordinator, 813-870-1292
- Recruiting
Cohen Medical Centers /ID# 278341
Thousand Oaks, California, 91360
- Recruiting
DM Clinical Research - Tomball /ID# 272452
Tomball, Texas, 77375
- Recruiting
Dm Clinical Research -Tomball Rch /ID# 281787
Tomball, Texas, 77377
- Recruiting
The Lundquist Institute /ID# 272481
Torrance, California, 90502
- Recruiting
Inland Rheumatology and Osteoporosis Medical Group /ID# 272449
Upland, California, 91786
- Recruiting
Sahni Rheumatology & Therapy /ID# 278352
West Long Branch, New Jersey, 07764
- Recruiting
Willow Rheumatology and Wellness /ID# 272691
Willowbrook, Illinois, 60527
Poland7 sites, 7 recruiting
- Recruiting
Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-068
- Recruiting
Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
- Recruiting
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966
Elblag, Warmian-Masurian Voivodeship, 82-300
- Recruiting
Malopolskie Centrum Kliniczne /ID# 272965
Krakow, Lesser Poland Voivodeship, 30-149
- Recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209
Krakow, Lesser Poland Voivodeship, 31-011
- Recruiting
Etyka Osrodek Badan Klinicznych /ID# 272974
Olsztyn, Warmian-Masurian Voivodeship, 10-117
- Recruiting
Centrum Medyczne Reuma Park /ID# 272968
Warsaw, Masovian Voivodeship, 02-665
Puerto Rico7 sites, 7 recruiting
- Recruiting
Clinical Research Investigator Group /ID# 274821
Bayamón, 00960
- Recruiting
Centro Reumatologico De Caguas /ID# 277918
Caguas, 00725
- Recruiting
Reuviva Research Center /ID# 277140
Guaynabo, 00968-8050
- Recruiting
Clinical Research Puerto Rico. /ID# 281346
San Juan, 00909-1738
- Recruiting
Santurce Clinical Trials and Infusion Center /ID# 277927
San Juan, 00909
Site Coordinator, 787-722-0662
- Recruiting
GCM Medical Group, PSC /ID# 273016
San Juan, 00917
- Recruiting
Mindful Medical Research /ID# 281521
San Juan, 00918-3756
Site Coordinator, 787-765-9034
Spain7 sites, 7 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruna /ID# 272609
A Coruña, 15006
- Recruiting
Hospital de Basurto /ID# 272610
Bilbao, Vizcaya, 48013
- Recruiting
Hospital Universitario Reina Sofia /ID# 272613
Córdoba, 14004
- Recruiting
Hospital General Universitario Gregorio Maranon /ID# 272616
Madrid, 28007
- Recruiting
Hospital Universitari Parc Tauli /ID# 272607
Sabadell, Barcelona, 08208
- Recruiting
Hospital Universitario de Valme /ID# 281266
Seville, Sevilla, 41014
- Recruiting
Consorci Hospital General Universitario de Valencia /ID# 272615
Valencia, 46014
Hungary6 sites, 6 recruiting
- Recruiting
Semmelweis Egyetem Reumatologiai es Immunologiai Klinika /ID# 273212
Budapest, 1023
- Recruiting
Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247
Budapest, 1027
- Recruiting
Qualiclinic /ID# 281259
Budapest, 1134
- Recruiting
Szegedi Tudomanyegyetem /ID# 272865
Szeged, Csongrád megye, 6720
- Recruiting
Complex Rendelo Med Zrt. /ID# 272859
Székesfehérvár, Fejér, 8000
- Recruiting
Vital-Medicina /ID# 272858
Veszprém, Fejér, 8200
Germany4 sites, 4 recruiting
- Recruiting
Universitaetsklinikum Bonn /ID# 272808
Bonn, North Rhine-Westphalia, 53127
- Recruiting
Krankenhaus Porz Am Rhein /ID# 272903
Cologne, North Rhine-Westphalia, 51149
- Recruiting
Mvz Rheuma /ID# 272795
Hamburg, 20095
- Recruiting
Rheumateam Lahn-Dill-Siegerland /ID# 274858
Wetzlar, Hesse, 35578
Serbia4 sites, 4 recruiting
- Recruiting
Institute Of Rheumatology /ID# 280054
Belgrade, Beograd, 11000
- Recruiting
Institute Of Rheumatology /ID# 280055
Belgrade, Beograd, 11000
- Recruiting
Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057
Novi Sad, Juznobacki Okrug, 21000
- Recruiting
Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058
Novi Sad, Juznobacki Okrug, 21000
South Korea4 sites, 4 recruiting
- Recruiting
SoonChunHyang University Hospital Cheonan /ID# 277624
Cheonan-si, Chungcheongnam-do, 31151
- Recruiting
Hanyang University Seoul Hospital /ID# 273625
Seoul, Seoul Teugbyeolsi, 04763
- Recruiting
SMG-SNU Boramae Medical Center /ID# 273627
Seoul, Seoul Teugbyeolsi, 07061
- Recruiting
Ajou University Hospital - Suwon-si /ID# 273647
Suwon, Gyeonggido, 16499
Canada3 sites, 3 recruiting
- Recruiting
Care Clinic - Calgary /ID# 274405
Calgary, Alberta, T2N 4L7
- Recruiting
Dr. Latha Naik Medical Professional Corporation /ID# 274403
Saskatoon, Saskatchewan, S7H 0P4
- Recruiting
Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273711
Sherbrooke, Quebec, J1G 2E8
Czechia3 sites, 3 recruiting
- Recruiting
L.K.N. Arthrocentrum /ID# 271932
Hlučín, Moravian-Silesian Region, 748 01
- Recruiting
MEDICAL PLUS Research s.r.o /ID# 271926
Uherské Hradiště, 686 01
- Recruiting
PV Medical Services /ID# 271934
Zlín, 760 01
Slovakia1 site, 1 recruiting
- Recruiting
MEDMAN s.r.o. /ID# 278688
Martin, Žilina Region, 036 01
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan General Hospital /ID# 280044
Taoyuan City, 330
About this study
Official title: A Phase 2, 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 causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).
This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Lutikizumab, Placebo, Ravagalimab
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutikizumabDrug
Subcutaneous (SC) injection
PlaceboDrug
Subcutaneous (SC) injection
RavagalimabDrug
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: Lutikizumab Monotherapy | Experimental | Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B Receives: Drug: Lutikizumab |
| Substudy 1: Matching Placebo Monotherapy | Placebo comparator | Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy. Receives: Drug: Placebo |
| Substudy 2: Ravagalimab Monotherapy | Experimental | Participants will be randomized to receive Ravagalimab Receives: Drug: Ravagalimab |
| Substudy 2: Matching Placebo Monotherapy | Placebo comparator | Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy Receives: Drug: Placebo |
| SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy | Experimental | Participants will be randomized to be administered Lutikizumab and Ravagalimab doses Receives: Drug: Lutikizumab; Drug: Ravagalimab |
| Substudy 3: Matching Placebo Combination Therapy | Placebo comparator | Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
- ≥ 50% improvement in 68-tender joint count;
- ≥ 50% improvement in 66-swollen joint count; and
- ≥ 50% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Health Assessment Questionnaire - Disability Index (HAQ-DI)
- High-sensitivity C-reactive protein (hsCRP)
Measured: At Week 12
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Week 22
Secondary outcomes (7)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
- ≥ 20% improvement in 68-tender joint count;
- ≥ 20% improvement in 66-swollen joint count; and
- ≥ 20% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Health Assessment Questionnaire - Disability Index (HAQ-DI)
- High-sensitivity C-reactive protein (hsCRP)
Measured: At Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:
- ≥ 70% improvement in 68-tender joint count;
- ≥ 70% improvement in 66-swollen joint count; and
- ≥ 70% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Health Assessment Questionnaire - Disability Index (HAQ-DI)
- High-sensitivity C-reactive protein (hsCRP)
Measured: At Week 12
Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). LDA is defined as a score of < or = to 3.2.
Measured: At Week 12
Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity). CR remission is defined as a score of less than 2.6
Measured: At Week 12
Change from Baseline in DAS28 (CRP)
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Measured: At Week 12
Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI)
The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. LDA is defined as a score from 2.8 to ≤ 10.
Measured: At Week 12
Percentage Of Participants Achieving CR per CDAI
The CDAI is a composite index for assessing disease activity. The total CDAI score ranges from 0 to 21 with higher scores indicating higher disease activity. CR remission is defined as a score of less than 2.8
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Jun 2025
- Primary completionFeb 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972446
- Sponsor's protocol ID
- M25-056
- Other IDs
- 2025-520721-21-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 7 May 2025
- Last updated
- 8 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06972446
- Acronym / sponsor ID
- M25-056
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).
This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: Lutikizumab Monotherapy | Experimental | Drug: LutikizumabParticipants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B |
| Substudy 1: Matching Placebo Monotherapy | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy. |
| Substudy 2: Ravagalimab Monotherapy | Experimental | Drug: RavagalimabParticipants will be randomized to receive Ravagalimab |
| Substudy 2: Matching Placebo Monotherapy | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy |
| SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy | Experimental | Drug: Lutikizumab, Drug: RavagalimabParticipants will be randomized to be administered Lutikizumab and Ravagalimab doses |
| Substudy 3: Matching Placebo Combination Therapy | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At any time prior to the Screening Visit, participant must have been treated for > or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. The maximum cap for prior use of b/tsDMARD is 2.
- Participant must be on a stable dose of methotrexate (MTX)
Key exclusion criteria (2 listed)
- Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone, alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditions unless they have been on stable doses for ≥ 1 week prior to Baseline Visit.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than rheumatoid arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LutikizumabSubcutaneous (SC) injection | Drug | SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy, Substudy 1: Lutikizumab Monotherapy |
| PlaceboSubcutaneous (SC) injection | Drug | Substudy 1: Matching Placebo Monotherapy, Substudy 2: Matching Placebo Monotherapy, Substudy 3: Matching Placebo Combination Therapy |
| RavagalimabSubcutaneous (SC) injection | Drug | SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy, Substudy 2: Ravagalimab Monotherapy |
Primary outcome
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Time frame: At Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Week 22
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
7 secondary outcomes
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Time frame: At Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Time frame: At Week 12
Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)
Time frame: At Week 12
Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)
Time frame: At Week 12
Change from Baseline in DAS28 (CRP)
Time frame: At Week 12
Percentage Of Participants Achieving LDA per Clinical Disease Activity Index (CDAI)
Time frame: At Week 12
Percentage Of Participants Achieving CR per CDAI
Time frame: At Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
96 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutikizumab and Ravagalimab in people with Rheumatoid Arthritis, run by AbbVie at 96 sites in 12 countries.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Poland, Puerto Rico, Spain, Hungary and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 With an American College of Rheumatology 50% (ACR50) Response (time frame: At 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?
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 8 Oct 2026.