A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT06570798
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Diagnosis of SLE and lupus nephritis (LN) according to 2019 European League Against<br> Rheumatism and the American College of Rheumatology classification criteria.<br><br> - Participant must be positive for at least one of the following autoantibodies:<br><br> 1. Antinuclear antibodies (ANA) = 1:80<br><br> 2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to<br> above normal range as established by central laboratory (ie, positive results)<br><br> 3. Anti-Smith antibodies elevated to above normal (ie, positive results).<br><br> - SLEDAI-2K = 8.<br><br> - Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or<br> without co-existing features of Class V LN according to 2018 International Society<br> of Nephrology/Renal Pathology Society (ISN/RPS) criteria. Renal biopsy must have<br> been performed within 6 months before enrollment. The local biopsy report will be<br> used. A central review center will confirm the eligibility.<br><br> - Inadequate response, for lack of efficacy or intolerance after 6 months to at least<br> two therapies at the maximally tolerated doses as recommended by the Kidney Disease:<br> Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is<br> defined as:<br><br> 1. UPCR = 1.5 mg/mg<br><br> 2. Less than 50% of proteinuria improvement in the past 3 months.<br><br>Exclusion Criteria:<br><br> - Estimated glomerular filtration rate (eGFR) of < 45 mL per minute per 1.73 m^2 of<br> body surface area (calculated using the Modification of Diet in Renal Disease [MDRD]<br> formula, with screening laboratory results for serum creatinine value).<br><br> - Significant likely irreversible organ damage related to SLE (eg, end-stage renal<br> disease [ESRD]).<br><br> - Any acute, severe lupus related flare during screening that needs immediate<br> treatment.<br><br> - A previous kidney transplant or planned transplant within study treatment period.<br><br> - History of or current renal diseases (other than LN) that in the opinion of the<br> investigator could interfere with the LN assessment and confound the disease<br> activity assessment (eg, diabetic nephropathy).<br><br> - Renal biopsy showing pure class V.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE);Number of Participants Who Experience a Serious TEAE
- Secondary Outcome Measures
Name Time Method Number of Participants With a 24-hour Urine Protein-creatinine Ratio (UPCR) = 0.5 mg/mg;Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS);Number of Participants With a Lupus Low Disease Activity State (LLDAS);Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score;Percent Change From Baseline in SLEDAI-2K Score;Change From Baseline in UPCR;Percent Change From Baseline in UPCR;Subprotocol A: Maximum Concentration (Cmax) of Inebilizumab;Subprotocol A: Time to Cmax (tmax) of Inebilizumab;Subprotocol A: Area Under the Concentration-time Curve (AUC) of Inebilizumab;Subprotocol B: Cmax of Blinatumomab;Subprotocol B: tmax of Blinatumomab;Subprotocol B: AUC of Blinatumomab;Subprotocol A: Number of Participants With Anti-inebilizumab Antibody Formation;Subprotocol B: Number of Participants With Anti-blinatumomab Antibody Formation