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Completed

NCT Number: NCT03978520

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685, Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has clinical diagnosis of Systemic Lupus Erythematosus (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 (SLE Disease Activity Index) ≥ 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 Principal Investigator (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).
  • No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

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.

Treatment and study plan

Elsubrutinib

Drug

Capsule; Oral

Other names: ABBV-105

Placebo for elsubrutinib

Drug

Capsule; Oral

Upadacitinib

Drug

Film-coated tablet; Oral

Other names: RINVOQ

Placebo for upadacitinib

Drug

Film-coated tablet; Oral

Primary outcomes

  1. Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24

    Time frame: Baseline, Week 24

    SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:

    • ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
    • No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
    • No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

Secondary outcomes

  1. Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24

    Time frame: Baseline, Week 24

    SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:

    • ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
    • No worsening of the overall condition (< 0.3 point increase in Physician's Global Assessment [PhGA])
    • No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.

  2. Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24

    Time frame: Baseline, Week 24

    BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment [PhGA], < 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.

  3. Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24

    Time frame: Baseline, Week 24

    LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score ≤4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA ≤1), and concomitant medication usage (steroid dose ≤7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).

  4. Change From Baseline in Daily Prednisone Dose at Week 24

    Time frame: From Baseline to Week 24

    Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.

  5. Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24

    Time frame: From Baseline to Week 24

    The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Acronym: SLEek

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2019
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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