A Phase 2a, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 and without nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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:

‣ Antinuclear antibodies (ANA) ≥ 1:80

⁃ Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)

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

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

• Subprotocol A and B (with LN): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B with LN) 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 B (SLE without nephritis): Systemic Lupus Erythematosus Disease Activity Index 2K ≥ 6.

• Subprotocol B (SLE without nephritis): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.

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

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

⁃ 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.

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

⁃ 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 DAS28-CRP \> 3.2 with at least 1 swollen joint at screening.

• Subprotocol C: Refractory disease defined as:

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

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

⁃ 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:

‣ Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.

⁃ Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.

Locations
United States
Arizona
HonorHealth Research and Innovation Institute
RECRUITING
Scottsdale
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Vida Research Center
TERMINATED
Hialeah
Homestead Associates In Research Inc
TERMINATED
Homestead
Vitaly Clinical Research
TERMINATED
Miami
New York
Northwell Health
RECRUITING
Great Neck
Ohio
MetroHealth Medical Center
RECRUITING
Cleveland
Texas
Prolato Clinical Research Center
RECRUITING
Houston
Other Locations
Australia
Linear Clinical Research Limited
RECRUITING
Perth
Belgium
Cliniques Universtaire Saint Luc Universite Catholique de Louvain
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Centre Hospitalier Universitaire de Liege - Sart Tilman
RECRUITING
Liège
France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
RECRUITING
Lille
Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot
RECRUITING
Lyon
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
RECRUITING
Lyon Cédex 3
Hopital de la Conception
RECRUITING
Marseille
Hopital Bichat Claude Bernard
RECRUITING
Paris
Hopital Cochin
RECRUITING
Paris
Hopital Europeen Georges Pompidou
RECRUITING
Paris
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
RECRUITING
Strasbourg
Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
RECRUITING
Strasbourg
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
RECRUITING
Toulouse
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
RECRUITING
Toulouse
Germany
Krankenhaus Porz am Rhein gGmbH
RECRUITING
Cologne
Universitaetsklinikum Duesseldorf AoeR
RECRUITING
Düsseldorf
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Klinikum der LMU Muenchen
RECRUITING
München
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Ospedale San Giovanni Bosco
RECRUITING
Torino
Portugal
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz
RECRUITING
Carnaxide
Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral
RECRUITING
Vila Franca De Xira
Unidade Local de Saude de Gaia-Espinho, EPE
RECRUITING
Vila Nova De Gaia
Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2029-06-23
Participants
Target number of participants: 98
Treatments
Experimental: Subprotocol A: Inebilizumab 3 Doses
Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.
Experimental: Subprotocol A: Inebilizumab 4 Doses
Participants will receive 4 doses of inebilizumab administered via an IV infusion.
Experimental: Subprotocol B: Blinatumomab Low-dose
Participants will receive blinatumomab low-dose administered via SC injection.
Experimental: Subprotocol B: Blinatumomab Medium-dose
Participants will receive blinatumomab medium-dose administered via SC injection.
Experimental: Subprotocol B: Blinatumomab High-dose
Participants will receive blinatumomab high-dose administered via SC injection.
Experimental: Subprotocol C: Blinatumomab Low-dose
Participants will receive blinatumomab low-dose administered via SC injection.
Experimental: Subprotocol C: Blinatumomab Medium-dose
Participants will receive blinatumomab medium-dose administered via SC injection.
Experimental: Subprotocol C: Blinatumomab High-dose
Participants will receive blinatumomab high-dose administered via SC injection.
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov