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NCT06570798 | RECRUITING | Systemic Lupus Erythematosus

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

Amgen

Brief 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).

Condition or disease

Systemic Lupus Erythematosus

Active Refractory Rheumatoid Arthritis

Intervention/treatment

Inebilizumab

Blinatumomab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 140 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2a, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2027-11-05
Estimated Study Completion Date : 2028-08-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.
  • * Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history
    • 1. Antinuclear antibodies (ANA) ≥ 1:80
    • 2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above 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 III or class IV with or without co-existing features of Class V LN according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
    • * Subprotocol A and B: Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 therapies (Subprotocol B) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg/mg
    • * Subprotocol A and B: If receiving any of the following medications, participants must 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. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable 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 of Associations 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) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).
          • * Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as
            • 1. Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.
            • 2. Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.
            Exclusion Criteria
            • * Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \< 30 mL per minute per 1.73 m\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \[MDRD\] formula, with screening laboratory results for serum creatinine 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 that needs immediate treatment.
            • * Subprotocol A and B: A previous kidney transplant or planned transplant within study treatment period.
            • * Subprotocol A and B: History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the 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 RA including but not limited to systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
            • * Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.
A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Location Details

NCT06570798

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

TERMINATED

United States, Florida

Life Research Center

Hialeah, Florida, United States, 33010

TERMINATED

United States, Florida

Homestead Associates In Research Inc

Homestead, Florida, United States, 33033

TERMINATED

United States, Florida

Vitaly Clinical Research

Miami, Florida, United States, 33125

RECRUITING

United States, New York

Northwell Health

Great Neck, New York, United States, 11021

RECRUITING

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

RECRUITING

United States, Texas

Prolato Clinical Research Center

Houston, Texas, United States, 77054

RECRUITING

Belgium,

Saint -Luc Universitis Catholic University of Louvain

Bruxelles, Belgium, 1200

RECRUITING

Belgium,

University Hospital Ghent

Gent, Belgium, 9000

RECRUITING

Belgium,

LIEGE University Hospital Center - SART TILMAN

Liege, Belgium, 4000

RECRUITING

France,

Regional University Hospital Center of Lille - HOPITAL CLAUDE HURIER

Little Cedex 01, France, 59037

RECRUITING

France,

Lyon University Hospital Center - EDOUARD HERRIOT HOPITAL

Lyon Cédex 3, France, 69437

RECRUITING

France,

Design hospital

Marseille, France, 13005

RECRUITING

France,

European hospital Georges Pompidou

Paris Cedex 15, France, 75908

RECRUITING

France,

Hospital Bichat Claude Bernard

Paris, France, 75018

RECRUITING

France,

Strasbourg University Hospital Center - Hautepierre hospital

Strasbourg Cedex, France, 67098

RECRUITING

France,

Strasbourg University Hospital Center - New Civil Hospital

Strasbourg, France, 67091

RECRUITING

France,

Toulouse University Hospital Center - Rangueil hospital

Toulouse Cedex 9, France, 31059

RECRUITING

Germany,

LMU Muenchen Clinic

MUENCHEN, Germany, 80336

RECRUITING

Italy,

IRCCS San Raffaele Hospital

Milano, Italy, 20132

RECRUITING

Italy,

IRCCS Humanitas Clinical Institute

Rozzano, Italy, 20089

RECRUITING

Spain, Cataluña

Clinic I Provincial Hospital of Barcelona

Barcelona, Cataluña, Spain, 08036

RECRUITING

Spain,

Vall d Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

October 12 University Hospital

Madrid, Spain, 28041

RECRUITING

United Kingdom,

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ