A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAmgen
About this trial
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 Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.
Antinuclear antibodies (ANA) ≥ 1:80
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
AntiSmith antibodies elevated to above normal (ie, positive results).
Disqualifiers
Subprotocol A, B and C: Receipt of a live and/or live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.
Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 30 mL per minute per 1.73 m² 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.
Trial design
Design model
Sequential
Treatments tested in this trial
Inebilizumab
DrugIV Infusion
Blinatumomab
DrugSC Injection
Treatment groups
220 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Subprotocol A: Inebilizumab 3 DosesExperimental treatment 1 intervention
Group B: Subprotocol A: Inebilizumab 4 DosesExperimental treatment 1 intervention
Group C: Subprotocol B Part A: Blinatumomab Low-doseExperimental treatment 1 intervention
Group D: Subprotocol B Part A: Blinatumomab Medium-doseExperimental treatment 1 intervention
Group E: Subprotocol B Part A: Blinatumomab High-doseExperimental treatment 1 intervention
Group F: Subprotocol B Part B: Dose ExpansionExperimental treatment 1 intervention
Group G: Subprotocol C Part A: Blinatumomab Low-doseExperimental treatment 1 intervention
Group H: Subprotocol C Part A: Blinatumomab Medium-doseExperimental treatment 1 intervention
Group I: Subprotocol C Part A: Blinatumomab High-doseExperimental treatment 1 intervention
Group J: Subprotocol C Part B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame
Day 1 to Week 522
Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE
Time frame
Day 1 to Week 523
Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)
Time frame
Week 524
Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)
Time frame
Week 26Secondary outcomes
1
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With CRR
Time frame
Subprotocol A and B Part A: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B: Week 12, Week 26, and Week 382
Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Partial Renal Response (PRR)
Time frame
Week 12, Week 26, Week 38, and Week 523
Subprotocol A and B: Number of Participants With Remission in SLE as Defined by DORIS
Time frame
Subprotocol A, B Part A, and B Part B Subgroup 1: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B Subgroup 2: Week 12, Week 38, and Week 524
Subprotocol A and B: Number of Participants With a Lupus Low Disease Activity State (LLDAS)
Time frame
Week 12, Week 26, Week 38, and Week 52 Source ClinicalTrials.gov