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TL011, anti CD20, for the treatment of rheumatoid arthritis

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Oct 4, 2021

Target and mechanism

ModalityMonoclonal antibody

Also known as TL011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

TL011, anti CD20, for the treatment of rheumatoid arthritis · 2 trials · 2 indications

Phase 1 2
NCT01205737A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma SubjectsDLBCL
COMPLETED186 Analytics
NCT01123070TL011 in Severe, Active Rheumatoid Arthritis PatientsRheumatoid Arthritis
COMPLETED54 Analytics
PHASE1COMPLETED
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
DLBCLUnlock trial analytics
PHASE1COMPLETED
TL011 in Severe, Active Rheumatoid Arthritis Patients
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC during a dosing interval for Rituximab
21 weeks
Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
Day 1 to Day 57

Secondary Endpoints

PK and PD parameters
Throughout study
Maximum Observed Concentration (Cmax) in Part B
Day 1 to Day 57
Number of Participants With Adverse Events in Part B
From randomization up to Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TL011EXPERIMENTAL -
MabThera®ACTIVE_COMPARATOR -
MabTheraACTIVE_COMPARATORMabThera infusions

Interventions

NameTypeDescription
TL011BIOLOGICAL375 mg/m2 iv every 3 weeks for 8 cycles
RituximabBIOLOGICAL375 mg/m2 iv every 3 weeks for 8 cycles
TL011, anti CD20, for the treatment of rheumatoid arthritisBIOLOGICALTL011 administered by 2 infusions, 2 weeks apart
MabThera infusionsBIOLOGICALMabThera, administered by 2 infusions, 2 weeks apart
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification. 2.CD20+ lymphoma cells at screening * 18-80 (inclusive) years of age at screening * Ann Arbor St...

Countries:BulgariaEstoniaFranceHungaryItalyLatviaPolandRussiaSpainUkraineCzechiaUnited Kingdom
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Frequently asked questions about TL011, anti CD20, for the treatment of rheumatoid arthritis

What is TL011?

TL011 is an investigational monoclonal antibody developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It has been studied in Phase 1 clinical trials for CD20-positive diffuse large B cell lymphoma (DLBCL) and for severe, active rheumatoid arthritis. It is not an approved therapy and remains in clinical development.

What is TL011 used for in rheumatoid arthritis?

TL011 was studied as a treatment for severe, active rheumatoid arthritis in adults 18 years and older. That Phase 1 trial, NCT01123070, was completed and enrolled 54 participants across Czechia, Hungary, Italy, Spain, and the United Kingdom. TL011 is investigational and has not been approved for rheumatoid arthritis.

What does TL011 target?

TL011 is an anti-CD20 monoclonal antibody, meaning it targets the CD20 protein found on B cells. This target class underlies its investigation in B cell lymphoma and in rheumatoid arthritis, where B cells contribute to disease activity. TL011 is a monoclonal antibody modality asset.

Who is developing TL011?

TL011 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 1 studies of TL011 in CD20-positive diffuse large B cell lymphoma and in severe, active rheumatoid arthritis.

What phase is TL011 in?

TL011 is in Phase 1 development. Both of its recorded trials were Phase 1 studies and both are completed, with no active trials currently listed. TL011 is investigational and has not been approved by the FDA for any indication.

What clinical trials is TL011 in?

TL011 has been evaluated in two completed Phase 1 trials. NCT01205737 was a double-blind, randomized, active-controlled study in CD20-positive diffuse B cell non-Hodgkin's lymphoma, enrolling 186 participants. NCT01123070 studied TL011 in severe, active rheumatoid arthritis and enrolled 54 participants.