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New treatment option for Systemic Lupus Erythematosus
Official title A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
ClinicalTrials.gov ID: NCT06570798
What this study is testing
What is Inebilizumab?
Inebilizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as Uplizna®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- \ Subprotocol B is no longer recruiting participants\
- Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR)...
- Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or...
- Antinuclear antibodies (ANA) ≥ 1:80
- Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can join
- \ Subprotocol B is no longer recruiting participants\
- 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)
- 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...
- 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...
- 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:
- 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.
- Methotrexate \> 25 mg/week and at a stable dose for 2 weeks
- Leflunomide \> 20 mg/day and at a stable dose for 2 weeks
- 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:
- 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.
- Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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:
- B-cell directed CAR T-cell and T-cell engager therapies
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Natalizumab
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Aurora, Colorado, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- South Miami, Florida, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Great Neck, New York, United States
- Hawthorne, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Perth, Western Australia, Australia
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Aurora, Colorado, United States; Hialeah, Florida, United States; Homestead, Florida, United States; Miami, Florida, United States; South Miami, Florida, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.