A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and side effects of inebilizumab and blinatumomab in adults with active lupus or rheumatoid arthritis that has not responded well to treatment. It also tests how well blinatumomab works when given as a shot under the skin. The lupus groups (A and B) are no longer taking new participants.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Group C: Have rheumatoid arthritis, a disease that causes swollen, painful joints, diagnosed using the study’s rules.
- Group C: Have moderate to severe disease, with at least 3 swollen joints and 3 tender joints at screening.
- Group C: Still have active disease after at least 1 standard disease-control drug, plus either 2 biologic drugs that work differently or 1 biologic and 1 targeted drug.
- Group C: Past drugs must have failed to control disease after at least 12 weeks, or caused side effects that made them hard to take.
- Group C, Part B: Have a blood test showing a level of inflammation at or above the lab’s upper normal limit.
- Groups A and B, now closed: Have lupus diagnosed using the study’s rules, a positive test for certain immune proteins, and enough disease activity to qualify.
- Groups A and B, now closed: Meet the group’s rules for past treatments that did not work or could not be tolerated. Kidney disease groups also need a kidney tissue test showing a qualifying type of lupus kidney inflammation.
- Groups A and B, now closed: Meet dose and timing rules for current medicines. Some Group B participants must also meet extra rules for disease activity in their organs.
Who can't join
- All groups: Receive a live vaccine within 4 weeks before the first study dose, during treatment, or before certain immune cells recover after treatment. Killed vaccines are allowed.
- All groups: Have ever received CAR T-cell or T-cell engager treatment aimed at B cells, radiation to the lymph system, a bone marrow transplant, T-cell vaccination treatment, or natalizumab.
- Groups B and C: Have a major brain or nerve condition, such as seizures, stroke, severe brain injury, dementia, or Parkinson’s disease. Group B also excludes active lupus affecting the brain or spinal cord within the past year.
- Group C: Have another disease that causes joint inflammation, or serious rheumatoid arthritis effects on other organs, such as blood vessel inflammation or lung scarring.
- Group C: Have the most severe level of limits on daily activities under the study’s rheumatoid arthritis rating system, called Class IV.
- Groups A and B: Have very low kidney function, major lupus-related organ damage likely to be permanent, or a severe lupus flare needing immediate treatment during screening.
- Groups A and B: Have had a kidney transplant or plan one during treatment. Kidney disease groups also exclude other kidney diseases that could affect study results.
- Group A: Have only class V lupus kidney disease on a kidney tissue test.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
\*Subprotocol A and B are no longer recruiting participants\* 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. AntiSmith antibodies elevated to above normal (ie, positive results). * Subprotocol A and B (Subgroup 1): 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: SLE Disease Activity Index 2K ≥ 6. * Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) 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 (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide. * Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems * Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1 * 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. 5. Methotrexate \> 25 mg/week and at a stable dose for 2 weeks 6. Leflunomide \> 20 mg/day and at a stable dose for 2 weeks 7. Dapsone \> 300 mg/day and at a stable dose for 2 weeks. * Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria. * Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP \> 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening. * Subprotocol C (Part A and Part B): Refractory disease defined as: * 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. * Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening. Exclusion Criteria: * 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 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 trial treatment period. * Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy). * Subprotocol A: Renal biopsy showing pure class V. * Subprotocol B: Active CNS Lupus within one year prior to screening. * Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome. * Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, 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. * Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1: 1. B-cell directed CAR T-cell and T-cell engager therapies 2. Total lymphoid irradiation 3. Bone marrow transplant 4. T-cell vaccination therapy 5. Natalizumab
Study sites (18)
AZ
- HonorHealth Research and Innovation Institute · Scottsdale, AZ 85258More trials in Scottsdale
CO
- University of Colorado · Aurora, CO 80045More trials in Aurora
FL
- Vida Research Center · Hialeah, FL 33010More trials in Hialeah
- Homestead Associates In Research Inc · Homestead, FL 33033More trials in Homestead
- Vitaly Clinical Research · Miami, FL 33125More trials in Miami
- Bioresearch Partner Coral Terrace · South Miami, FL 33143More trials in South Miami
LA
- University Medical Center New Orleans · New Orleans, LA 70112More trials in New Orleans
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
MN
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
NY
- Northwell Health · Great Neck, NY 11021More trials in Great Neck
- Westchester Medical Center · Hawthorne, NY 10532More trials in Hawthorne
- Columbia University Medical Center · New York, NY 10032More trials in New York
- University of Rochester Medical Center · Rochester, NY 14642More trials in Rochester
OH
- MetroHealth Medical Center · Cleveland, OH 44109More trials in Cleveland
- The Metro Health System Main Campus · Cleveland, OH 44109More trials in Cleveland
- Cleveland Clinic Foundation · Cleveland, OH 44195More trials in Cleveland
TX
- Prolato Clinical Research Center · Houston, TX 77054More trials in Houston
WA
- Seattle Rheumatology Associates · Seattle, WA 98104More trials in Seattle