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A Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03978520
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 vs placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses for further development.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus (SLE) Drug: ABBV-105 Drug: Placebo for ABBV-105 Drug: Upadacitinib Drug: Placebo for upadacitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : September 16, 2021
Estimated Study Completion Date : March 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Group 1: Upadacitinib and ABBV-105
Participants will be administered with ABBV-105 dose A and upadacitinib dose A
Drug: ABBV-105
ABBV-105 is administered orally as capsule

Drug: Upadacitinib
Upadacitinib is administered orally as a tablet

Experimental: Group 2: Upadacitinib and ABBV-105
Participants will be administered with ABBV-105 dose A and upadacitinib dose B
Drug: ABBV-105
ABBV-105 is administered orally as capsule

Drug: Upadacitinib
Upadacitinib is administered orally as a tablet

Experimental: Group 3: ABBV-105 and Placebo for Updadacitinib
Participants will be administered with ABBV-105 dose A and placebo for upadacitinib
Drug: ABBV-105
ABBV-105 is administered orally as capsule

Drug: Placebo for upadacitinib
Placebo for upadacitinib is administered orally as a tablet

Experimental: Group 4: Upadacitinib and Placebo for ABBV-105
Participants will be administered with placebo for ABBV-105 and upadacitinib dose A
Drug: Placebo for ABBV-105
Placebo for ABBV-105 is administered orally as capsule

Drug: Upadacitinib
Upadacitinib is administered orally as a tablet

Experimental: Group 5: Placebo for ABBV-105 and Placebo for Upadacitinib
Participants will be administered with placebo for ABBV-105 and placebo for upadacitinib
Drug: Placebo for ABBV-105
Placebo for ABBV-105 is administered orally as capsule

Drug: Placebo for upadacitinib
Placebo for upadacitinib is administered orally as a tablet




Primary Outcome Measures :
  1. SLE Responder Index (SRI)-4 and steroid dose <= 10 mg prednisone equivalent QD [ Time Frame: Week 24 ]
    Composite of SRI-4 and steroid dose <= 10 mg prednisone equivalent QD based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems is evaluated.


Secondary Outcome Measures :
  1. SLE Responder Index (SRI)-4 [ Time Frame: Up to Week 48 ]
    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.

  2. SLE Responder Index (SRI)-5 [ Time Frame: Up to Week 48 ]
    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.

  3. SLE Responder Index (SRI)-6 [ Time Frame: Up to Week 48 ]
    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.

  4. SLE Responder Index (SRI)-7 [ Time Frame: Up to Week 48 ]
    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.

  5. SLE Responder Index (SRI)-8 [ Time Frame: Up to Week 48 ]
    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.

  6. British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) [ Time Frame: Up to Week 48 ]
    BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.

  7. Lupus Low Disease Activity State (LLDAS) [ Time Frame: Up to Week 48 ]
    LLDAS is a state of low disease activity based on SLEDAI score, absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment, and concomitant medication usage. SLEDAI is the SLE disease activity index focuses on high-impact disease manifestations across organ systems. Scores range from 0 to 105, with higher scores indicating more severe disease

  8. Change in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2000 (2K) from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    SLEDAI-2K is global SLE disease activity index that focuses on high-impact disease manifestations across the organ systems.

  9. Change in Steroid Burden from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    Steroid Burden is measured as milligrams (mg) of prednisolone administered.

  10. Number of flares by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index [ Time Frame: Up to Week 48 ]
    SELENA SLEDAI flare index defines SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.

  11. Time to first flare by SELENA SLEDAI flare index after first study drug administration [ Time Frame: Up to Week 48 ]
    SELENA SLEDAI flare index defines SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.

  12. Reduction in Number of Tender or Swollen Lupus joints [ Time Frame: Up to Week 48 ]
    Reduction in number of Tender or Swollen Lupus joints of those starting with >= 6 affected joints is assessed by physical examination

  13. Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score by 50% [ Time Frame: Up to Week 48 ]
    CLASI is an index used to assess cutaneous manifestations of SLE summarizing the activity of the disease.

  14. Change in British Isles Lupus Assessment Group (BILAG) from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    BILAG is a global SLE disease activity index designed on the basis of the physician's intention to treat, focusing on changes in disease manifestations.

  15. Change in Physician's Global Assessment from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    Participant's overall disease activity due to SLE, as compared with all possible patients with SLE is assessed by physician.

  16. Change in Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-F) from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    FACIT-F is a patient-reported questionnaire developed to assess fatigue. The responses to the items on the FACIT-F questionnaire are each measured on a 4-point Likert scale.

  17. Change in Short Form (SF)-36 from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    SF-36 is a general Health Related Quality of Life (HRQoL) instrument which comprises 36 total questions targeting participant's functional health and well-being.

  18. Change Lupus Quality of Life (LupusQoL) from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    The Lupus Quality of Life (LupusQoL) is a disease-specific Health Related Quality of Life (HRQoL) patient reported outcome (PRO) instrument.

  19. Change in Pain Numerical Rating Scale (NRS) from Baseline [ Time Frame: From Baseline (Week 0) to Week 48 ]
    The pain NRS scale is a single item questionnaire in which participants are asked to rate the overall pain level. The pain NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
  • At Screening, must have at least one of the following:

    • antinuclear antibody(ANA)+ (titer >= 1:80)
    • anti-dsDNA+
    • anti-Smith+
  • SLEDAI-2K >= 6 as reported and independently adjudicated (clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at Screening. If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints. If participant has rash and PI considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
  • Physician's Global Assessment (PhGA) >= 1 during screening period
  • Background treatment, stable for 30 days, at Baseline with prednisone, antimalarials, azathioprine, mycophenolate, leflunomide cyclosporine, tacrolimus, and/or methotrexate (MTX).

    • The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) and a single, but not multiple, additional immunosuppressant is permitted.

Exclusion Criteria:

  • Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978520


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Arizona
Arizona Arthritis & Rheumatolo /ID# 211329 Not yet recruiting
Phoenix, Arizona, United States, 85032-9306
United States, Arkansas
Arthritis and Rheumatism Associates /ID# 211411 Not yet recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Wallace Rheumatic Studies Ctr /ID# 211600 Not yet recruiting
Beverly Hills, California, United States, 90211
Valerius Medical Group /ID# 211599 Not yet recruiting
Los Alamitos, California, United States, 90720
East Bay Rheumatology Medical /ID# 211638 Not yet recruiting
San Leandro, California, United States, 94578
Medvin Clinical Research /ID# 211996 Not yet recruiting
Tujunga, California, United States, 91042-2706
United States, Connecticut
Yale University /ID# 211546 Not yet recruiting
New Haven, Connecticut, United States, 06510
Yale University /ID# 212824 Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
LeJenue Research Associates /ID# 212327 Not yet recruiting
Miami, Florida, United States, 33126
Integral Rheumatology & Immunology Specialists /ID# 213053 Not yet recruiting
Plantation, Florida, United States, 33324
W. Broward Rheum Assoc Inc. /ID# 211881 Not yet recruiting
Tamarac, Florida, United States, 33321
United States, Illinois
Affinity Health /ID# 211496 Not yet recruiting
Oak Brook, Illinois, United States, 60523-1245
Deerbrook Medical Associates /ID# 212251 Not yet recruiting
Vernon Hills, Illinois, United States, 60061
United States, Louisiana
LSUHSC - Shreveport /ID# 211412 Not yet recruiting
Shreveport, Louisiana, United States, 71103
United States, Maine
Rheumatology Associates,PA /ID# 211578 Not yet recruiting
Portland, Maine, United States, 04102
United States, Maryland
The Center for Rheumatology and Bone Research /ID# 211610 Not yet recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Beth Israel Deaconess Medical Center /ID# 212321 Not yet recruiting
Boston, Massachusetts, United States, 02215-5400
United States, Michigan
Henry Ford Health System /ID# 211676 Not yet recruiting
Detroit, Michigan, United States, 48202
June DO, PC /ID# 211674 Recruiting
Lansing, Michigan, United States, 48910
United States, New York
NYU Langone Ambulatory Care Brooklyn Heights /ID# 211548 Not yet recruiting
Brooklyn, New York, United States, 11201
United States, Ohio
STAT Research, Inc. /ID# 211404 Not yet recruiting
Dayton, Ohio, United States, 45417-3445
United States, Tennessee
Dr. Ramesh Gupta /ID# 213381 Not yet recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Tekton Research, Inc. /ID# 211521 Not yet recruiting
Austin, Texas, United States, 78745
Trinity Universal Res Assoc /ID# 211527 Not yet recruiting
Carrollton, Texas, United States, 75007
SW Rheumatology Res. LLC /ID# 211520 Not yet recruiting
Mesquite, Texas, United States, 75150
United States, Washington
Virginia Mason Medical Center /ID# 211457 Not yet recruiting
Seattle, Washington, United States, 98101
United States, West Virginia
Rheumatology and Pulmonary cli /ID# 211398 Not yet recruiting
Beckley, West Virginia, United States, 25801
Argentina
Aprillus Asistencia e Investig /ID# 211630 Not yet recruiting
Capital Federal, Buenos Aires, Argentina, 1046
Hospital Interzonal Gral Agudos San Martin /ID# 211679 Not yet recruiting
La Plata, Buenos Aires, Argentina, 1906
Hospital General de Agudos Ram /ID# 212801 Not yet recruiting
Buenos Aires, Argentina, C1221ADC
Hospital Cordoba /ID# 212200 Not yet recruiting
Cordoba, Argentina, 5004
Instituto CAICI /ID# 211633 Not yet recruiting
Rosario, Santa FE, Argentina, 2000
Centro Medico Privado/Reuma /ID# 212714 Not yet recruiting
San Miguel de Tucuman, Argentina, 4000
Investigaciones Clin Tucuman /ID# 211942 Not yet recruiting
San Miguel de Tucuman, Argentina, 4000
Centro de Enfermedades /ID# 211634 Not yet recruiting
Santa Fe, Argentina, 2000
Australia, Queensland
Royal Brisbane and Women's Hospital /ID# 212667 Not yet recruiting
Herston, Queensland, Australia, 4029
Rheumatology Research Unit /ID# 211902 Not yet recruiting
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
The Queen Elizabeth Hospital /ID# 211901 Not yet recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Monash Health /ID# 212313 Not yet recruiting
Clayton, Victoria, Australia, 3168
St. Vincents Hosp Melbourne /ID# 212311 Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Canada, Ontario
St. Josephs Health Care Centre /ID# 212331 Not yet recruiting
London, Ontario, Canada, N6A 4V2
China, Shanghai
Shanghai Changhai Hospital /ID# 211819 Not yet recruiting
Shanghai, Shanghai, China, 200433
China
Peking Union Med College Hosp /ID# 211614 Not yet recruiting
Beijing, China, 100730
Xiangya Hospital Central South University /ID# 212919 Not yet recruiting
Changsha, China, 410008
People's Hospital of Xinjiang /ID# 211821 Not yet recruiting
Urumqi, China, 830001
Colombia
Centro de Investigaciòn en Reumatologia CIREEM /ID# 211895 Not yet recruiting
Bogota, Cundinamarca, Colombia, 110221
Ctr Int de Reum del Caribe SAS /ID# 211894 Not yet recruiting
Barranquilla, Colombia, 80002
Preventive Care Sas /Id# 211896 Not yet recruiting
Chia, Colombia, 250001
Clinica Universitaria Bolivari /ID# 211897 Not yet recruiting
Medellin, Colombia, 050034
Healthy Medical Center SAS /ID# 211899 Not yet recruiting
Zipaquira, Colombia, 250252
France
CHRU Lille - Hôpital Claude Huriez /ID# 211829 Not yet recruiting
Lille CEDEX, Hauts-de-France, France, 59045
CHU Bordeaux-Hopital Pellegrin /ID# 211832 Not yet recruiting
Bordeaux, France, 33076
CHU Bicetre /ID# 211968 Not yet recruiting
Le Kremlin Bicetre, France, 94270
CHU Paris-GH La Pitie Salpetri /ID# 211831 Not yet recruiting
Paris, France, 75013
Hôpital Civil /ID# 211981 Not yet recruiting
Strasbourg CEDEX, France, 67091
Germany
Charité - Med Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie /ID# 211988 Not yet recruiting
Berlin, Germany, 10117
Universitätsklinikum Freiburg /ID# 211990 Not yet recruiting
Freiburg, Germany, 79106
Hungary
Vital Medical Center Orvosi es /ID# 212796 Not yet recruiting
Veszprém, Veszprem, Hungary, 8200
Orszagos Reumatologiai es Fizi /ID# 211827 Not yet recruiting
Budapest, Hungary, 1023
Debreceni Egyetem /ID# 212042 Not yet recruiting
Debrecen, Hungary, 4032
Zala Megyei Korhaz /ID# 212955 Not yet recruiting
Zalaegerszeg, Hungary, 8900
Italy
AOU Arcispedale Sant Anna di /ID# 211861 Not yet recruiting
Cona, Italy, 44124
Korea, Republic of
Ajou University Hospital /ID# 211692 Not yet recruiting
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Inha University Hospital /ID# 211691 Not yet recruiting
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Chonnam National University Hospital /ID# 211695 Not yet recruiting
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Konkuk University Medical Ctr /ID# 213410 Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
Seoul National University Hospital /ID# 211740 Not yet recruiting
Seoul, Korea, Republic of, 03080
Mexico
Centro Integral en Reumatología S.A de C.V /ID# 211876 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44160
Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 212532 Not yet recruiting
Guadalajara, Jalisco, Mexico, 44690
Medical Care & Research SA de CV /ID# 212682 Not yet recruiting
Mérida, Yucatan, Mexico, 97070
RM Pharma Specialists, S.A de C.V /ID# 211879 Not yet recruiting
Mexico City, Mexico, 03100
(CINTRE) Centro de Investigac. /ID# 211875 Not yet recruiting
Mexico City, Mexico, 11850
New Zealand
Waikato Hospital /ID# 213505 Not yet recruiting
Hamilton, Waikato, New Zealand, 3204
North Shore Hospital /ID# 213506 Not yet recruiting
Auckland, New Zealand, 0622
Middlemore Clinical Trials /ID# 213504 Not yet recruiting
Auckland, New Zealand, 2025
Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 212482 Not yet recruiting
Wrocław, Dolnoslaskie, Poland, 51-685
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o. /ID# 212146 Not yet recruiting
Krakow, Poland, 31-011
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu /ID# 212483 Not yet recruiting
Poznań, Poland, 61-544
Puerto Rico
GCM Medical Group /ID# 211251 Not yet recruiting
San Juan, Puerto Rico, 00909
Mindful Medical Research /ID# 213384 Not yet recruiting
San Juan, Puerto Rico, 00918-3756
Spain
Corporac Sanitaria Parc Tauli /ID# 212145 Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Comple Hosp Univ de A Coruna /ID# 211719 Not yet recruiting
A Coruna, Spain, 15006
Hospital Universitario Basurto /ID# 212722 Not yet recruiting
Bilbao, Spain, 48013
Hospital Universitario Galdakao /Id# 212803 Not yet recruiting
Galdakao, Spain, 48960
Hosp Univ 12 de Octubre /ID# 211757 Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario de Valm /ID# 212721 Not yet recruiting
Sevilla, Spain, 41014
Hospital Universitario La Fe /ID# 211720 Not yet recruiting
Valencia, Spain, 46026
Hospital de Alava /ID# 212520 Not yet recruiting
Vitoria, Spain, 01009
Taiwan
China Medical University Hosp /ID# 212179 Not yet recruiting
Taichung City, Taichung, Taiwan, 40447
National Taiwan University Hospital /ID# 211752 Not yet recruiting
Taipei City, Taipei, Taiwan, 100
Taichung Veterans General Hosp /ID# 211957 Not yet recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 212216 Not yet recruiting
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 211751 Not yet recruiting
Taoyuan City, Taiwan, 33305
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03978520     History of Changes
Other Study ID Numbers: M19-130
2019-000638-20 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Systemic Lupus Erythematosus (SLE)
ABBV-105
Upadacitinib
ABBV-599

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases