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

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title:

A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451772
• Other study ID #: M20-186
• Secondary ID: 2020-001690-72
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2020
• Est. completion date: January 3, 2024

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 100 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 information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: January 3, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib, upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching placebo) 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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

Intervention

Drug:
• Elsubrutinib
Oral; Capsule
• Placebo for Elsubrutinib
Oral; Capsule
• Upadacitinib
Oral; Tablet
• Placebo for Upadacitinib
Oral; Tablet

Locations

Country	Name	City	State
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Aprillus Asistencia e Investigacion /ID# 221890	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893	La Plata	Buenos Aires
Argentina	CER Instituto Medico /ID# 223175	Quilmes	Buenos Aires
Argentina	Instituto CAICI S.R.L /ID# 221892	Rosario	Santa Fe
Argentina	Centro de Investigaciones Medicas Tucuman /ID# 221888	San Miguel de Tucuman	Tucuman
Argentina	Investigaciones Clinicas Tucuman /ID# 221889	San Miguel de Tucuman	Tucuman
Australia	Emeritus Research /ID# 223027	Camberwell	Victoria
Australia	Monash Medical Centre /ID# 221814	Clayton	Victoria
Australia	Rheumatology Research Unit Sunshine Coast /ID# 221816	Maroochydore	Queensland
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 223358	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 223359	Sofia
China	Peking Union Medical College Hospital /ID# 222950	Beijing	Beijing
China	Guangdong Provincial People's Hospital /ID# 222851	Guangzhou	Guangdong
China	Huashan Hospital, Fudan University /ID# 222929	Shanghai	Shanghai
China	People's Hospital of Xinjiang /ID# 222928	Urumqi
Colombia	Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879	Barranquilla	Atlantico
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 221884	Bogota	Cundinamarca
Colombia	Preventive Care Sas /Id# 221881	Chia	Cundinamarca
Colombia	Clinica Universitaria Bolivari /ID# 221880	Medellin
Colombia	Healthy Medical Center SAS /ID# 221882	Zipaquira	Cundinamarca
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963	Berlin
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964	Dresden
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 222480	Debrecen	Hajdu-Bihar
Hungary	Vital Medicina Kft /ID# 222479	Veszprém	Veszprem
Italy	Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919	Cona	Ferrara
Japan	National Hospital Organization Asahikawa Medical Center /ID# 222394	Asahikawa-shi	Hokkaido
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 222393	Hiroshima-shi	Hiroshima
Japan	EIRAKU Internal Medicine Clinic /ID# 222385	Kagoshima-shi	Kagoshima
Japan	Saitama Medical Center /ID# 222389	Kawagoe-shi	Saitama
Japan	Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499	Kitakyushu-shi	Fukuoka
Japan	Shinshu University Hospital /ID# 222395	Matsumoto-shi	Nagano
Japan	Chukyo Hospital /ID# 223398	Nagoya-shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 222397	Nagoya-shi	Aichi
Japan	Tohoku University Hospital /ID# 222392	Sendai-shi	Miyagi
Japan	Keio University Hospital /ID# 222498	Shinjuku-ku	Tokyo
Korea, Republic of	Seoul National University Hospital /ID# 221897	Seoul
Mexico	Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910	Guadalajara	Jalisco
Mexico	Centro Integral en Reumatologia S.A de C.V /ID# 221914	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 221912	Leon	Guanajuato
Mexico	Medical Care & Research SA de CV /ID# 221911	Mérida	Yucatan
Mexico	CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913	Mexico City	Ciudad De Mexico
Mexico	RM Pharma Specialists S.A de C.V. /ID# 221915	Mexico City	Ciudad De Mexico
New Zealand	North Shore Hospital /ID# 221850	Takapuna	Auckland
Poland	Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430	Krakow	Malopolskie
Poland	Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859	Poznan	Wielkopolskie
Poland	MTZ Clinical Research Powered by Pratia /ID# 224431	Warszawa	Mazowieckie
Poland	WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860	Wroclaw	Dolnoslaskie
Puerto Rico	GCM Medical Group PSC /ID# 224394	San Juan
Puerto Rico	Mindful Medical Research /ID# 222513	San Juan
Spain	Hospital Universitario A Coruna - CHUAC /ID# 221993	A Coruna
Spain	Hospital Universitario Basurto /ID# 221999	Bilbao	Vizcaya
Spain	Hospital Universitario de Galdakao /ID# 221996	Galdakao	Vizcaya
Spain	Hospital Universitario 12 de Octubre /ID# 221994	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995	Sabadell	Barcelona
Spain	Hospital Universitario Virgen de Valme /ID# 221997	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 221998	Valencia
Spain	HUA - Txagorritxu /ID# 221992	Vitoria	Alava
Taiwan	China Medical University Hospital /ID# 221747	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 221748	Taichung
Taiwan	Taipei Veterans General Hosp /ID# 221746	Taipei
Taiwan	National Taiwan University Hospital /ID# 221745	Taipei City
Taiwan	Taipei Medical University Hospital /ID# 227653	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 222469	Taoyuan City
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 221863	London	London, City Of
United Kingdom	Manchester University NHS Foundation Trust /ID# 221861	Manchester
United States	University of Colorado Hospital /ID# 245087	Aurora	Colorado
United States	Tekton Research, Inc. /ID# 224411	Austin	Texas
United States	Arthritis & Rheumatic Disease Specialties /ID# 227828	Aventura	Florida
United States	Wallace Rheumatic Studies Center, LLC /ID# 224374	Beverly Hills	California
United States	Beth Israel Deaconess Medical Center /ID# 222505	Boston	Massachusetts
United States	Qualmedica Research, LLC /ID# 227817	Evansville	Indiana
United States	Accurate Clinical Management /ID# 225509	Houston	Texas
United States	June DO, PC /ID# 221841	Lansing	Michigan
United States	Deerbrook Medical Associates /ID# 227330	Libertyville	Illinois
United States	Valerius Medical Group & Research Center /ID# 223922	Los Alamitos	California
United States	Dr. Ramesh Gupta /ID# 225524	Memphis	Tennessee
United States	SW Rheumatology Res. LLC /ID# 225485	Mesquite	Texas
United States	NYU Langone Health/NYU School of Medicine /ID# 245088	New York	New York
United States	Millennium Research /ID# 233192	Ormond Beach	Florida
United States	AZ Arthritis and Rheumotology Research, PLLC /ID# 227833	Phoenix	Arizona
United States	Allegheny Health Network Research Institute /ID# 245086	Pittsburgh	Pennsylvania
United States	IRIS Research and Development, LLC /ID# 227814	Plantation	Florida
United States	Carilion Clinic /ID# 227832	Roanoke	Virginia
United States	East Bay Rheumatology Medical /ID# 225493	San Leandro	California
United States	STAT Research, Inc. /ID# 221840	Vandalia	Ohio
United States	The Center for Rheumatology and Bone Research /ID# 225479	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  China,  Colombia,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Poland,  Puerto Rico,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.	Through Week 108
Secondary	Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4	SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.	Through Week 104
Secondary	Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)	BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.	Through Week 104
Secondary	Change in Steroid Burden	Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.	Baseline of M19-130 (Week 0) Through Week 104
Secondary	Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)	SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.	Through Week 104