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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

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ClinicalTrials.gov Identifier: NCT03978520
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03978520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus (SLE)
Intervention  ICMJE
  • Drug: ABBV-105
    ABBV-105 is administered orally as capsule
  • Drug: Placebo for ABBV-105
    Placebo for ABBV-105 is administered orally as capsule
  • Drug: Upadacitinib
    Upadacitinib is administered orally as a tablet
  • Drug: Placebo for upadacitinib
    Placebo for upadacitinib is administered orally as a tablet
Study Arms  ICMJE
  • Experimental: Group 1: Upadacitinib and ABBV-105
    Participants will be administered with ABBV-105 dose A and upadacitinib dose A
    Interventions:
    • Drug: ABBV-105
    • Drug: Upadacitinib
  • Experimental: Group 2: Upadacitinib and ABBV-105
    Participants will be administered with ABBV-105 dose A and upadacitinib dose B
    Interventions:
    • Drug: ABBV-105
    • Drug: Upadacitinib
  • Experimental: Group 3: ABBV-105 and Placebo for Updadacitinib
    Participants will be administered with ABBV-105 dose A and placebo for upadacitinib
    Interventions:
    • Drug: ABBV-105
    • Drug: Placebo for upadacitinib
  • Experimental: Group 4: Upadacitinib and Placebo for ABBV-105
    Participants will be administered with placebo for ABBV-105 and upadacitinib dose A
    Interventions:
    • Drug: Placebo for ABBV-105
    • Drug: Upadacitinib
  • Experimental: Group 5: Placebo for ABBV-105 and Placebo for Upadacitinib
    Participants will be administered with placebo for ABBV-105 and placebo for upadacitinib
    Interventions:
    • Drug: Placebo for ABBV-105
    • Drug: Placebo for upadacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2019)
310
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
325
Estimated Study Completion Date  ICMJE March 18, 2022
Estimated Primary Completion Date September 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   China,   Colombia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978520
Other Study ID Numbers  ICMJE M19-130
2019-000638-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP