A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

Study Purpose

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 nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subprotocol A and B: Diagnosis of SLE and lupus nephritis (LN) 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: 1.
Antinuclear antibodies (ANA) ≥ 1:80. 2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range as established by central laboratory (ie, positive results) 3. Anti-Smith antibodies elevated to above normal (ie, positive results).
  • - Subprotocol A and B: SLEDAI-2K ≥ 8.
  • - Subprotocol A and B: Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.
Renal biopsy must have been performed within 6 months before enrollment. The local biopsy report will be used. A central review center will confirm the eligibility.
  • - Subprotocol A and B: Inadequate response, for lack of efficacy or intolerance after 6 months to at least 1 therapy (Subprotocol A) or 2 therapies (Subprotocol B) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024).
Inadequate response is defined as: 1. UPCR ≥ 1.5 mg/mg. 2. Less than 50% of proteinuria improvement in the past 3 months.
  • - 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 having all the following criteria: 1.
DAS28-CRP > 3.2 at screening. 2. at least 6 tender joints at screening. 3. at least 6 swollen joints at screening.
  • - Subprotocol C: Refractory disease defined as: - Moderate to severe 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.

Exclusion Criteria:

  • - Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 45 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 study treatment period.
  • - Subprotocol A and B: History of or current renal diseases (other than LN) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
  • - Subprotocol A and B: Renal biopsy showing pure class V.
  • - Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to systemic lupus erythematosus, 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06570798
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries Belgium, France, Germany, Italy, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

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.

Interventions

Drug: - Inebilizumab

Intravenous (IV) Infusion

Drug: - Blinatumomab

SC Injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vida Research Center, Hialeah, Florida

Status

Address

Vida Research Center

Hialeah, Florida, 33010

Homestead Associates In Research Inc, Homestead, Florida

Status

Address

Homestead Associates In Research Inc

Homestead, Florida, 33033

Vitaly Clinical Research, Miami, Florida

Status

Address

Vitaly Clinical Research

Miami, Florida, 33125

Northwell Health, Great Neck, New York

Status

Address

Northwell Health

Great Neck, New York, 11021

Prolato Clinical Research Center, Houston, Texas

Status

Address

Prolato Clinical Research Center

Houston, Texas, 77054

International Sites

Liege, Belgium

Status

Address

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liege, , 4000

Lyon Cédex 3, France

Status

Address

Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

Lyon Cédex 3, , 69437

Strasbourg, France

Status

Address

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, , 67091

Toulouse Cedex 9, France

Status

Address

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse Cedex 9, , 31059

Klinikum der LMU Muenchen, Muenchen, Germany

Status

Address

Klinikum der LMU Muenchen

Muenchen, , 80336

IRCCS Ospedale San Raffaele, Milano, Italy

Status

Address

IRCCS Ospedale San Raffaele

Milano, , 20132

IRCCS Istituto Clinico Humanitas, Rozzano, Italy

Status

Address

IRCCS Istituto Clinico Humanitas

Rozzano, , 20089