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Tralokinumab Dose 1

Phase 2

Atopic Dermatitis | Monoclonal antibody | Dermatology |AstraZeneca PLC|Last Updated: May 23, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

Tralokinumab Dose 1 · 1 trial · 1 indication

Phase 2 1
NCT02347176Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic DermatitisAtopic Dermatitis
COMPLETED204 Analytics
PHASE2COMPLETED
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
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Study Endpoints

Primary Endpoints

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Baseline (Day 1) and Week 12

EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
Week 12

The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
From Study Drug Administration (Day 1) to Week 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1EXPERIMENTALTralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2EXPERIMENTALTralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3EXPERIMENTALTralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Interventions

NameTypeDescription
PlaceboOTHERSubcutaneous injection with placebo
Tralokinumab Dose 1BIOLOGICALSubcutaneous injection with tralokinumab
Tralokinumab Dose 2BIOLOGICALSubcutaneous injection with tralokinumab
Tralokinumab Dose 3BIOLOGICALSubcutaneous injection with tralokinumab
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Physician diagnosis of atopic dermatitis for greater than (\>) 1 year * Atopic dermatitis involvement of greater than or equal to (\>=) 10 percent (%) body surface area * EASI score of \>= 12 * SCORAD of \>= 25 * IGA score of \>= 3 * Effective birth control in line with protoc...

Countries:United StatesAustraliaCanadaGermanyJapanPoland
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Frequently asked questions about Tralokinumab Dose 1

What is Tralokinumab used for?

Tralokinumab is an investigational monoclonal antibody being studied for uncontrolled asthma, ulcerative colitis, asthma, and atopic dermatitis. It is developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development for these indications.

What does Tralokinumab target?

Tralokinumab is a monoclonal antibody that targets interleukin-13 (IL-13), a cytokine involved in inflammatory responses. By binding to IL-13, it aims to modulate the inflammatory pathways implicated in conditions like asthma and ulcerative colitis.

Who makes Tralokinumab?

Tralokinumab is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety in respiratory and inflammatory conditions.

What phase is Tralokinumab in?

Tralokinumab is in Phase 3 clinical development. It has completed Phase 3 trials for uncontrolled asthma, and earlier phase trials have been completed for ulcerative colitis and asthma. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is Tralokinumab in?

Tralokinumab has been studied in several clinical trials, including NCT02161757, a Phase 3 study in adults and adolescents with uncontrolled asthma, and NCT01482884, a Phase 2 study in patients with active, moderate-to-severe ulcerative colitis. Other trials include NCT01592396 and NCT02085473.

Is Tralokinumab the same as CAT-354?

Yes, Tralokinumab is also known as CAT-354. In a Phase 1 study (NCT01592396), the drug was referred to as Tralokinumab (CAT-354), confirming that these names refer to the same investigational monoclonal antibody.