A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Study Purpose

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body, in participants who completed study M19-130. This study will assess the change in disease symptoms. ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus Erythematosus (SLE). This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260 participants will be enrolled in the study in approximately 146 sites worldwide. Participants will receive the following for up to 56 weeks: Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same treatment in this study. Participants who were receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms in this study. Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the course of 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination) and will not have developed any laboratory or clinical discontinuation criteria as defined in that study.
  • - On stable background treatment for SLE throughout the study.

Exclusion Criteria:

  • - Active, chronic, or recurrent viral, or bacterial infection.
  • - Active tuberculosis (TB) - History of gastrointestinal (GI) perforation, diverticulitis, or a significantly increased risk for GI perforation per investigator assessment.
  • - Participant require vaccination with live vaccine during study participation.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04451772
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Argentina, Bulgaria, China, Germany, Hungary, Japan, Mexico, Netherlands, Poland, Puerto Rico, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus (SLE)
Arms & Interventions

Arms

Experimental: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A

Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).

Experimental: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B

Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.

Experimental: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo

Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.

Experimental: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A

Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.

Interventions

Drug: - Elsubrutinib

Oral; Capsule

Drug: - Placebo for Elsubrutinib

Oral; Capsule

Drug: - Upadacitinib

Oral; Tablet

Drug: - Placebo for Upadacitinib

Oral; Tablet

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beverly Hills, California

Status

Address

Wallace Rheumatic Studies Ctr /ID# 224374

Beverly Hills, California, 90211

Valerius Med Grp & Res Ctr /ID# 223922, Los Alamitos, California

Status

Address

Valerius Med Grp & Res Ctr /ID# 223922

Los Alamitos, California, 90720-5402

San Leandro, California

Status

Address

East Bay Rheumatology Medical /ID# 225493

San Leandro, California, 94578

Wheaton, Maryland

Status

Address

The Center for Rheumatology and Bone Research /ID# 225479

Wheaton, Maryland, 20902

Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center /ID# 222505

Boston, Massachusetts, 02215-5400

June DO, PC /ID# 221841, Lansing, Michigan

Status

Address

June DO, PC /ID# 221841

Lansing, Michigan, 48910

STAT Research, Inc. /ID# 221840, Vandalia, Ohio

Status

Address

STAT Research, Inc. /ID# 221840

Vandalia, Ohio, 45377-9464

Dr. Ramesh Gupta /ID# 225524, Memphis, Tennessee

Status

Address

Dr. Ramesh Gupta /ID# 225524

Memphis, Tennessee, 38119

Tekton Research, Inc. /ID# 224411, Austin, Texas

Status

Address

Tekton Research, Inc. /ID# 224411

Austin, Texas, 78745

Accurate Clinical Management /ID# 225509, Baytown, Texas

Status

Address

Accurate Clinical Management /ID# 225509

Baytown, Texas, 77521

SW Rheumatology Res. LLC /ID# 225485, Mesquite, Texas

Status

Address

SW Rheumatology Res. LLC /ID# 225485

Mesquite, Texas, 75150

International Sites

Capital Federal, Buenos Aires, Argentina

Status

Address

Aprillus Asistencia e Investig /ID# 221890

Capital Federal, Buenos Aires, 1046

La Plata, Buenos Aires, Argentina

Status

Address

Hospital Interzonal Gral Agudos San Martin /ID# 221893

La Plata, Buenos Aires, 1906

CER Instituto Medico /ID# 223175, Quilmes, Buenos Aires, Argentina

Status

Address

CER Instituto Medico /ID# 223175

Quilmes, Buenos Aires, 1878

Fundacion Respirar /ID# 223174, Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina

Status

Address

Fundacion Respirar /ID# 223174

Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, 1426

Centro Medico Privado/Reuma /ID# 221888, San Miguel de Tucuman, Ciuadad Autonoma De Buenos Aires, Argentina

Status

Address

Centro Medico Privado/Reuma /ID# 221888

San Miguel de Tucuman, Ciuadad Autonoma De Buenos Aires, 4000

Instituto CAICI SRL /ID# 221892, Rosario, Santa Fe, Argentina

Status

Address

Instituto CAICI SRL /ID# 221892

Rosario, Santa Fe, 2000

Buenos Aires, Argentina

Status

Address

Hospital Militar Central Ciruj /ID# 222569

Buenos Aires, , 1426

Hospital Cordoba /ID# 221894, Cordoba, Argentina

Status

Address

Hospital Cordoba /ID# 221894

Cordoba, , 5000

Investigaciones Clin Tucuman /ID# 221889, San Miguel de Tucuman, Argentina

Status

Address

Investigaciones Clin Tucuman /ID# 221889

San Miguel de Tucuman, , 4000

Santa Fe, Argentina

Status

Address

Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 221891

Santa Fe, , 2000

MHAT Kaspela /ID# 223360, Plovdiv, Bulgaria

Status

Address

MHAT Kaspela /ID# 223360

Plovdiv, , 4001

UMHAT Sv. Ivan Rilski /ID# 223358, Sofia, Bulgaria

Status

Address

UMHAT Sv. Ivan Rilski /ID# 223358

Sofia, , 1612

UMHAT Sv. Ivan Rilski /ID# 223359, Sofia, Bulgaria

Status

Address

UMHAT Sv. Ivan Rilski /ID# 223359

Sofia, , 1612

Anhui Provincial Hospital /ID# 222854, Hefei, Anhui, China

Status

Address

Anhui Provincial Hospital /ID# 222854

Hefei, Anhui, 230001

Changsha, Hunan, China

Status

Address

Xiangya Hospital Central South University /ID# 222850

Changsha, Hunan, 410008

Shanghai, Shanghai, China

Status

Address

Huashan Hospital of Fudan University /ID# 222929

Shanghai, Shanghai, 200040

Beijing, China

Status

Address

Peking Union Med College Hosp /ID# 222950

Beijing, , 100730

Jiangsu Province Hospital /ID# 222948, Nanjing, China

Status

Address

Jiangsu Province Hospital /ID# 222948

Nanjing, , 210029

Urumqi, China

Status

Address

People's Hospital of Xinjiang /ID# 222928

Urumqi, , 830001

Dusseldorf, Nordrhein-Westfalen, Germany

Status

Address

Universitaetsklinikum Duesseldorf /ID# 222966

Dusseldorf, Nordrhein-Westfalen, 40225

Berlin, Germany

Status

Address

Charité - Med Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie /ID# 222963

Berlin, , 10117

Dresden, Germany

Status

Address

Universitaetsklinikum Dresden /ID# 222964

Dresden, , 01307

Univ Hosp Schleswig-Holstein /ID# 222962, Kiel, Germany

Status

Address

Univ Hosp Schleswig-Holstein /ID# 222962

Kiel, , 24105

Debrecen, Hungary

Status

Address

Debreceni Egyetem Klinikai Kozpont /ID# 222480

Debrecen, , 4032

Veszprem, Hungary

Status

Address

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 222479

Veszprem, , 8200

Asahikawa-shi, Hokkaido, Japan

Status

Address

National Hospital Organization Asahikawa Medical Center /ID# 222394

Asahikawa-shi, Hokkaido, 070-8644

Tomakomai City Hospital /ID# 222398, Tomakomai-shi, Hokkaido, Japan

Status

Address

Tomakomai City Hospital /ID# 222398

Tomakomai-shi, Hokkaido, 053-0034

Shinshu University Hospital /ID# 222395, Matsumoto-shi, Nagano, Japan

Status

Address

Shinshu University Hospital /ID# 222395

Matsumoto-shi, Nagano, 390-8621

Mexico City, Ciudad De Mexico, Mexico

Status

Address

CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913

Mexico City, Ciudad De Mexico, 11850

Leon, Guanajuato, Mexico

Status

Address

Morales Vargas Centro de Investigacion S.C. /ID# 221912

Leon, Guanajuato, 37000

Guadalajara, Jalisco, Mexico

Status

Address

Centro Integral en Reumatologia S.A de C.V /ID# 221914

Guadalajara, Jalisco, 44160

Guadalajara, Jalisco, Mexico

Status

Address

Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910

Guadalajara, Jalisco, 44690

San Luis Potosí, San Luis Potosi, Mexico

Status

Address

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, SC /ID# 223389

San Luis Potosí, San Luis Potosi, 78213

Mérida, Yucatan, Mexico

Status

Address

Medical Care & Research SA de CV /ID# 221911

Mérida, Yucatan, 97070

Mexico City, Mexico

Status

Address

RM Pharma Specialists S.A de C.V /ID# 221915

Mexico City, , 03100

Amsterdam, Netherlands

Status

Address

Vrije Universiteit Medisch Centrum /ID# 221776

Amsterdam, , 1081 HV

Leiden, Netherlands

Status

Address

Leids Universitair Medisch Centrum /ID# 221774

Leiden, , 2333 ZA

Utrecht, Netherlands

Status

Address

Universitair Medisch Centrum Utrecht /ID# 221775

Utrecht, , 3584 CX

Wrocław, Dolnoslaskie, Poland

Status

Address

WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860

Wrocław, Dolnoslaskie, 51-685

Krakow, Poland

Status

Address

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430

Krakow, , 31-011

Poznań, Poland

Status

Address

Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859

Poznań, , 61-545

Warsaw, Poland

Status

Address

Centrum Medyczne Pratia Warszawa /ID# 224431

Warsaw, , 01-868

GCM Medical Group, PSC /ID# 224394, San Juan, Puerto Rico

Status

Address

GCM Medical Group, PSC /ID# 224394

San Juan, , 00917

Mindful Medical Research /ID# 222513, San Juan, Puerto Rico

Status

Address

Mindful Medical Research /ID# 222513

San Juan, , 00918-3756

A Coruña, A Coruna, Spain

Status

Address

Hospital Universitario A Coruña - CHUAC /ID# 221993

A Coruña, A Coruna, 15006

Sabadell, Barcelona, Spain

Status

Address

Hospital Parc Tauli de Sabadell /ID# 221995

Sabadell, Barcelona, 08208

Bilbao, Spain

Status

Address

Hospital Universitario Basurto /ID# 221999

Bilbao, , 48013

Galdakao, Spain

Status

Address

Hospital Universitario de Galdakao /ID# 221996

Galdakao, , 48960

Madrid, Spain

Status

Address

Hospital Universitario 12 de Octubre /ID# 221994

Madrid, , 28041

Sevilla, Spain

Status

Address

Hospital Universitario Virgen de Valme /ID# 221997

Sevilla, , 41014

Valencia, Spain

Status

Address

Hospital Universitario y Politecnico La Fe /ID# 221998

Valencia, , 46026

HUA - Txagorritxu /ID# 221992, Vitoria, Spain

Status

Address

HUA - Txagorritxu /ID# 221992

Vitoria, , 01009

Taichung City, Taichung, Taiwan

Status

Address

China Medical University Hosp /ID# 221747

Taichung City, Taichung, 40447

National Taiwan Univ Hosp /ID# 221745, Taipei City, Taipei, Taiwan

Status

Address

National Taiwan Univ Hosp /ID# 221745

Taipei City, Taipei, 10002

Taichung City, Taiwan

Status

Address

Taichung Veterans General Hosp /ID# 221748

Taichung City, , 40705

Taipei Veterans General Hosp /ID# 221746, Taipei City, Taiwan

Status

Address

Taipei Veterans General Hosp /ID# 221746

Taipei City, , 11217

Taoyuan City, Taiwan

Status

Address

Linkou Chang Gung Memorial Ho /ID# 222469

Taoyuan City, , 33305