A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Last updated: June 4, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

2

Condition

Connective Tissue Diseases

Lupus

Cutaneous Lupus Erythematosus

Treatment

Inebilizumab

Blinatumomab

Clinical Study ID

NCT06570798
20240033
2024-514382-19
  • Ages 18-75
  • All Genders

Study Summary

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subprotocol A and B: Diagnosis of SLE according to 2019 European League AgainstRheumatism and the American College of Rheumatology (ACR) classification criteria.

  • Subprotocol A and B: Participant must be positive for at least one of the followingautoantibodies at screening (performed by central laboratory) or through documentedhistory:

  1. Antinuclear antibodies (ANA) ≥ 1:80

  2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated toabove normal range (ie, positive results)

  3. Anti-Smith antibodies elevated to above normal (ie, positive results).

  • Subprotocol A and B: Active, biopsy-proven, proliferative LN demonstrating class IIIor class IV with or without co-existing features of Class V LN according to 2018International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. Thelocal biopsy report will be used.

  • Subprotocol A and B: Inadequate response, loss of response or intolerance to atleast 1 therapy (Subprotocol A) or 2 therapies (Subprotocol B) at the maximallytolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0mg/mg

  • Subprotocol A and B: If receiving any of the following medications, participantsmust be on these doses prior to day 1:

  1. Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms)and at a stable dose for 5 days

  2. Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Otherequivalent antimalarials (chloroquine, quinacrine) are also accepted at astable dose for 4 weeks.

  3. MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.

  4. AZA dose ≤ 2 mg/kg/day and at a stable dose for 2 weeks.

  • Subprotocol C: Diagnosis of RA according to the 2010 ACR/ European Alliance ofAssociations for Rheumatology (EULAR) classification criteria.

  • Subprotocol C: Active disease defined as having all the following criteria:

  1. DAS28-CRP > 3.2 at screening

  2. at least 6 tender joints at screening

  3. at least 6 swollen joints at screening

  • Subprotocol C: Refractory disease defined as:

  • Moderate to severe active disease despite having received treatment with:

  1. at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND

  2. at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) ofdifferent mechanisms of action OR 1 bDMARD and at least 1 targeted syntheticdisease-modifying antirheumatic drugs (tsDMARD).

  • Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should bedefined as:
  1. Participant having active disease despite a minimum of 12 weeks of treatmentwith a csDMARD, bDMARD, or tsDMARD.

  2. Intolerance to treatment as defined by participant having experienced anadverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.

Exclusion

Exclusion Criteria:

  • Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 30 mL perminute per 1.73 m^2 of body surface area (calculated using the Modification of Dietin Renal Disease [MDRD] formula, with screening laboratory results for serumcreatinine value).

  • Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease [ESRD]).

  • Subprotocol A and B: Any acute, severe lupus related flare during screening thatneeds immediate treatment.

  • Subprotocol A and B: A previous kidney transplant or planned transplant within studytreatment period.

  • Subprotocol A and B: History of or current renal diseases (other than LN) that inthe opinion of the investigator could interfere with the LN assessment and confoundthe disease activity assessment (eg, diabetic nephropathy).

  • Subprotocol A and B: Renal biopsy showing pure class V.

  • Subprotocol C: Prior history of current inflammatory joint disease other than RAincluding but not limited to systemic lupus erythematosus, mixed connective tissuedisorder, scleroderma, polymyositis, or significant systemic involvement secondaryto RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).

  • Subprotocol C: Functional Class IV as defined by the ACR classification offunctional status in RA.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Inebilizumab
Phase: 2
Study Start date:
June 14, 2025
Estimated Completion Date:
March 14, 2027

Connect with a study center

  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 4000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille cedex 01, 59037
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

    Lyon Cédex 3, 69437
    France

    Active - Recruiting

  • Hopital de la Conception

    Marseille, 13005
    France

    Active - Recruiting

  • Hopital Bichat Claude Bernard

    Paris, 75018
    France

    Active - Recruiting

  • Hopital Europeen Georges Pompidou

    Paris cedex 15, 75908
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse Cedex 9, 31059
    France

    Active - Recruiting

  • Klinikum der LMU Muenchen

    Muenchen, 80336
    Germany

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Cataluña 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • HonorHealth Research and Innovation Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Vida Medical Research

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Vida Research Center

    Hialeah, Florida 33010
    United States

    Terminated

  • Homestead Associates In Research Inc

    Homestead, Florida 33033
    United States

    Terminated

  • Vitaly Clinical Research

    Miami, Florida 33125
    United States

    Terminated

  • Northwell Health

    Great Neck, New York 11021
    United States

    Active - Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

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