Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 despite background therapy 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.
  • Score must be re-confirmed at the Baseline visit.
  • Physician's Global Assessment (PhGA) >= 1 during screening period
  • Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg), azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (<=20 mg).
  • The combination of background treatment with antimalarial(s) and/or prednisone (or equivalent) is permitted
  • And a single, but not multiple, additional immunosuppressant from the list above, 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Medstar Health Research Institute /ID# 213335
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.