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TCS

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Roche Holding AG|Last Updated: Oct 2, 2017

Target and mechanism

ModalitySmall molecule

Also known as TCS Cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment212

FDA Designations

No designations recorded

Clinical trial landscape

TCS · 1 trial · 1 indication

Phase 2 1
NCT02340234A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic DermatitisAtopic Dermatitis
COMPLETED212 Analytics
PHASE2COMPLETED
A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis
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Study Endpoints

Primary Endpoints

Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12
Week 12

Secondary Endpoints

Percent Change From Baseline in EASI Score at Week 12
Baseline, Week 12
Absolute Change From Baseline in EASI Score at Week 12
Baseline, Week 12
Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lebrikizumab 250 mg Single Dose + TCS CreamEXPERIMENTALParticipants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Lebrikizumab 125 mg Single Dose + TCS CreamEXPERIMENTALParticipants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Lebrikizumab 125 mg Q4W + TCS CreamEXPERIMENTALParticipants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.
Placebo Q4W + TCS CreamPLACEBO_COMPARATORParticipants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Interventions

NameTypeDescription
LebrikizumabDRUGLebrikizumab will be administered SC as per the schedule specified in the respective arms.
PlaceboDRUGPlacebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS CreamDRUGTCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites74

Inclusion Criteria: * AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening * Moderate to severe AD as graded by the Rajka/Langeland criteria at screening * History of inadequate response to a \>/= 1 month (within the 3 months prior to the screening v...

Countries:United StatesAustraliaCanadaCzechiaFinlandFranceGermanyNetherlandsPolandSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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