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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

NCT ID: NCT03682705

Last Updated: 2021-05-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2020-03-26

Brief Summary

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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.

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Detailed Description

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This was a 12-week, randomized, double-blind, parallel-group, Phase 2, dose exploratory, multicenter study. Participants who met eligibility criteria were randomized in a 3:2:2:2:2:1 ratio to 1 of 6 treatment groups: ABBV-599 \[UPA 15 mg/ELS 60 mg\]); ELS 60 mg/UPA placebo; ELS 20 mg/UPA placebo; ELS 5 mg/UPA placebo; UPA 15 mg/ELS placebo; and ELS placebo/UPA placebo. The study included a 35-day maximum screening period and a 12-week treatment period with 30-day follow-up.

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ELS placebo/UPA placebo

Placebo capsule for elsubrutinib once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo for elsubrutinib

Intervention Type DRUG

Placebo capsule for elsubrutinib will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Placebo tablet for upadacitinib will be administered orally.

UPA 15 mg/ELS 60 mg

15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; 60 mg elsubrutinib capsule once a day by mouth for 12 weeks

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Upadacitinib

Intervention Type DRUG

Upadacitinib tablet will be administered orally.

ELS 60 mg/UPA placebo

60 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Placebo tablet for upadacitinib will be administered orally.

ELS 20 mg/UPA placebo

20 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Placebo tablet for upadacitinib will be administered orally.

ELS 5 mg/UPA placebo

5 mg elsubrutinib capsule once a day by mouth for 12 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 12 weeks

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Placebo tablet for upadacitinib will be administered orally.

UPA 15 mg/ELS placebo

15 mg film-coated upadacitinib tablet once a day by mouth for 12 weeks; placebo capsule for elsubrutinib once a day by mouth for 12 weeks

Group Type EXPERIMENTAL

Upadacitinib

Intervention Type DRUG

Upadacitinib tablet will be administered orally.

Placebo for elsubrutinib

Intervention Type DRUG

Placebo capsule for elsubrutinib will be administered orally.

Interventions

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Elsubrutinib

Elsubrutinib capsule will be administered orally.

Intervention Type DRUG

Upadacitinib

Upadacitinib tablet will be administered orally.

Intervention Type DRUG

Placebo for elsubrutinib

Placebo capsule for elsubrutinib will be administered orally.

Intervention Type DRUG

Placebo for upadacitinib

Placebo tablet for upadacitinib will be administered orally.

Intervention Type DRUG

Other Intervention Names

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ABBV-105 ABT-494

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Rheum Assoc of North Alabama /ID# 167382

Huntsville, Alabama, United States

Site Status

AZ Arthritis & Rheum Research /ID# 167446

Mesa, Arizona, United States

Site Status

SunValley Arthritis Center, Lt /ID# 213073

Peoria, Arizona, United States

Site Status

AZ Arthritis and Rheum Researc /ID# 167448

Phoenix, Arizona, United States

Site Status

St. Joseph Heritage Healthcare /ID# 167379

Fullerton, California, United States

Site Status

Purushotham, Akther & Roshan K /ID# 168121

La Mesa, California, United States

Site Status

Valerius Medical Group /ID# 168123

Los Alamitos, California, United States

Site Status

Sierra Rheumatology /ID# 167976

Roseville, California, United States

Site Status

Rheumatology Center of San Diego /ID# 170690

San Diego, California, United States

Site Status

Iraj Sabahi Research, Inc /ID# 201923

Turlock, California, United States

Site Status

Inland Rheum Clin Trials Inc. /ID# 167459

Upland, California, United States

Site Status

Medvin Clinical Research /ID# 205731

Whittier, California, United States

Site Status

Rheumatology Consultants of De /ID# 208238

Lewes, Delaware, United States

Site Status

Bay Area Arthritis and Osteo /ID# 208111

Brandon, Florida, United States

Site Status

Clinical Res of West FL, Inc. /ID# 167462

Clearwater, Florida, United States

Site Status

Omega Research Maitland, LLC /ID# 167376

DeBary, Florida, United States

Site Status

Riverside Clinical Research /ID# 167982

Edgewater, Florida, United States

Site Status

Lakes Research, LLC /ID# 170660

Miami, Florida, United States

Site Status

Kendall South Medical Center, Inc. /ID# 206857

Miami, Florida, United States

Site Status

Medallion Clinical Research Institute, LLC /ID# 201710

Naples, Florida, United States

Site Status

Rheum Assoc of Central FL /ID# 170858

Orlando, Florida, United States

Site Status

HMD Research LLC /ID# 208381

Orlando, Florida, United States

Site Status

International Medical Research - Ormond /ID# 170864

Ormond Beach, Florida, United States

Site Status

Millennium Research /ID# 167453

Ormond Beach, Florida, United States

Site Status

Arthritis Center, Inc. /ID# 170695

Palm Harbor, Florida, United States

Site Status

Integral Rheumatology & Immunology Specialists /ID# 206724

Plantation, Florida, United States

Site Status

BayCare Medical Group /ID# 170860

St. Petersburg, Florida, United States

Site Status

St. Anthony Comprehensive Rese /ID# 170668

St. Petersburg, Florida, United States

Site Status

Clinical Research of West Florida, Inc /ID# 169099

Tampa, Florida, United States

Site Status

ForCare Clinical Research /ID# 206280

Tampa, Florida, United States

Site Status

Florida Medical Clinic /ID# 206279

Zephyrhills, Florida, United States

Site Status

Institute of Arthritis Researc /ID# 170694

Idaho Falls, Idaho, United States

Site Status

Great Lakes Clinical Trials /ID# 167471

Chicago, Illinois, United States

Site Status

Clinical Investigation Specialists - Skokie /ID# 167468

Skokie, Illinois, United States

Site Status

Deerbrook Medical Associates /ID# 207098

Vernon Hills, Illinois, United States

Site Status

PRN of Kansas /ID# 167985

Wichita, Kansas, United States

Site Status

The Arthritis & Diabetes Clinic, Inc. /ID# 170682

Monroe, Louisiana, United States

Site Status

Mansfield Health Center /ID# 167372

Mansfield, Massachusetts, United States

Site Status

Advanced Clinical Care /ID# 167367

Worcester, Massachusetts, United States

Site Status

June DO, PC /ID# 170670

Lansing, Michigan, United States

Site Status

Beals Instititute /ID# 170658

Lansing, Michigan, United States

Site Status

Arthritis Associates /ID# 209075

Hattiesburg, Mississippi, United States

Site Status

North Mississippi Med Clinics /ID# 167377

Tupelo, Mississippi, United States

Site Status

Clayton Medical Associates dba Saint Louis Rheumatology /ID# 170650

St Louis, Missouri, United States

Site Status

Physician Research Collaboration, LLC /ID# 200480

Lincoln, Nebraska, United States

Site Status

Dhmc /Id# 167476

Lebanon, New Hampshire, United States

Site Status

Ocean Rheumatology /ID# 170673

Toms River, New Jersey, United States

Site Status

Arthritis and Osteo Assoc /ID# 167443

Las Cruces, New Mexico, United States

Site Status

DJL Clinical Research, PLLC /ID# 167374

Charlotte, North Carolina, United States

Site Status

EmergeOrtho, P.A. /ID# 209154

Durham, North Carolina, United States

Site Status

Cape Fear Arthritis Care /ID# 167413

Leland, North Carolina, United States

Site Status

New Horizons Clinical Research /ID# 170862

Blue Ash, Ohio, United States

Site Status

Marietta Memorial Hospital /ID# 210968

Marietta, Ohio, United States

Site Status

STAT Research, Inc. /ID# 200485

Vandalia, Ohio, United States

Site Status

Health Research of Oklahoma /ID# 167370

Oklahoma City, Oklahoma, United States

Site Status

Clinical Research Ctr Reading /ID# 170708

Wyomissing, Pennsylvania, United States

Site Status

West Tennessee Research Inst /ID# 167366

Jackson, Tennessee, United States

Site Status

Nashville Arthritis and Rheumatology /ID# 206699

Nashville, Tennessee, United States

Site Status

Amarillo Ctr for Clin Research /ID# 200484

Amarillo, Texas, United States

Site Status

Tekton Research, Inc. /ID# 167475

Austin, Texas, United States

Site Status

Trinity Universal Res Assoc /ID# 209252

Carrollton, Texas, United States

Site Status

Arth and Osteo Clin Brazo Valley /ID# 209401

College Station, Texas, United States

Site Status

Metroplex Clinical Research /ID# 167458

Dallas, Texas, United States

Site Status

Rheumatic Disease Clin Res Ctr /ID# 167474

Houston, Texas, United States

Site Status

Rheumatology Clinic of Houston /ID# 203689

Houston, Texas, United States

Site Status

Accurate Clinical Research /ID# 207059

Houston, Texas, United States

Site Status

West Texas Clinical Research /ID# 205732

Lubbock, Texas, United States

Site Status

SW Rheumatology Res. LLC /ID# 167383

Mesquite, Texas, United States

Site Status

Trinity Universal Research Association /ID# 209253

Plano, Texas, United States

Site Status

Sun Research Institute /ID# 170667

San Antonio, Texas, United States

Site Status

Accurate Clinical Management /ID# 200481

San Antonio, Texas, United States

Site Status

DM Clinical Research /ID# 167444

Tomball, Texas, United States

Site Status

Arthritis & Osteoporosis Clinic /ID# 167407

Waco, Texas, United States

Site Status

Tidewater Physicians Medical Center /ID# 210884

Newport News, Virginia, United States

Site Status

Western Washington Arthritis C /ID# 205821

Bothell, Washington, United States

Site Status

Arthritis Northwest, PLLC /ID# 200479

Spokane, Washington, United States

Site Status

Rheumatology and Pulmonary cli /ID# 170863

Beckley, West Virginia, United States

Site Status

Aurora Rheumatology and Immunotherapy Center /ID# 167385

Franklin, Wisconsin, United States

Site Status

CUB Hospital Erasme /ID# 201965

Brussels, Brussels Capital, Belgium

Site Status

Cliniques Universitaires Saint Luc /ID# 201756

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status

UZ Ghent /ID# 201757

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Leuven /ID# 201927

Leuven, , Belgium

Site Status

Rheumatology Research Assoc /ID# 207299

Edmonton, Alberta, Canada

Site Status

Manitoba Clinic /ID# 202126

Winnipeg, Manitoba, Canada

Site Status

CIADS Research Co Ltd /ID# 202125

Winnipeg, Manitoba, Canada

Site Status

Credit Valley Rheumatology /ID# 202124

Mississauga, Ontario, Canada

Site Status

Mount Sinai Hosp.-Toronto /ID# 202652

Toronto, Ontario, Canada

Site Status

Dr. Latha Naik /ID# 212972

Saskatoon, Saskatchewan, Canada

Site Status

Revmatolog s.r.o. /ID# 202610

Jihlava, Jihlava, Czechia

Site Status

Revmatologicky ustav Praha /ID# 202142

Prague, Praha 2, Czechia

Site Status

Revmatologie MUDr. Klara Sirova /ID# 205185

Ostrava, , Czechia

Site Status

CCR Czech a.s /ID# 202144

Pardubice, , Czechia

Site Status

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 202439

Miskolc, Borsod-Abauj Zemplen county, Hungary

Site Status

Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 202441

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status

Revita Reumatologiai Rendelo /ID# 202438

Budapest, , Hungary

Site Status

CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 205804

Székesfehérvár, , Hungary

Site Status

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 202437

Veszprém, , Hungary

Site Status

Malopolskie Centrum Kliniczne /ID# 206473

Krakow, Lesser Poland Voivodeship, Poland

Site Status

McBk Sc /Id# 212575

Grodzisk Mazowiecki, Masovian Voivodeship, Poland

Site Status

NBR Polska /ID# 206476

Warsaw, Masovian Voivodeship, Poland

Site Status

ClinicMed Daniluk, Nowak Sp.j. /ID# 212576

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Reumatika - Centrum Reumatologii NZOZ /ID# 206472

Warsaw, , Poland

Site Status

GCM Medical Group, PSC /ID# 167983

San Juan, , Puerto Rico

Site Status

Hospital Universitario A Coruña - CHUAC /ID# 202140

A Coruña, A Coruna, Spain

Site Status

Hospital Unversitario Marques de Valdecilla /ID# 202133

Santander, Cantabria, Spain

Site Status

Hospital Regional de Malaga /ID# 202137

Málaga, Malaga, Spain

Site Status

Hospital Clinic /ID# 206575

Barcelona, , Spain

Site Status

Hospital Santa Creu i Sant Pau /ID# 206535

Barcelona, , Spain

Site Status

Hospital Universitario Basurto /ID# 206462

Bilbao, , Spain

Site Status

Hospital Universitario Virgen de las Nieves /ID# 209705

Granada, , Spain

Site Status

Hospital Clinico Universitario San Carlos /ID# 202135

Madrid, , Spain

Site Status

Hospital Universitario y Politecnico La Fe /ID# 202139

Valencia, , Spain

Site Status

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 201976

Newcastle upon Tyne, , United Kingdom

Site Status

University of Oxford /ID# 201974

Oxford, , United Kingdom

Site Status

Warrington and Halton Teaching Hosp NHS Foundation Trust /ID# 206002

Warrington, , United Kingdom

Site Status

Countries

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United States Belgium Canada Czechia Hungary Poland Puerto Rico Spain United Kingdom

References

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Fleischmann R, Friedman A, Drescher E, Singhal A, Cortes-Maisonet G, Doan T, Lu W, Wang Z, Nader A, Housley W, Cohen S, Taylor PC, Blanco R. Safety and efficacy of elsubrutinib or upadacitinib alone or in combination (ABBV-599) in patients with rheumatoid arthritis and inadequate response or intolerance to biological therapies: a multicentre, double-blind, randomised, controlled, phase 2 trial. Lancet Rheumatol. 2022 Jun;4(6):e395-e406. doi: 10.1016/S2665-9913(22)00092-3. Epub 2022 Apr 27.

Reference Type DERIVED
PMID: 38293957 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-000666-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M16-063

Identifier Type: -

Identifier Source: org_study_id

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