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1=Etanercept

Phase 3

Psoriasis | Small molecule | Dermatology |Amgen Inc.|Last Updated: Aug 7, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment592

FDA Designations

No designations recorded

Clinical trial landscape

1=Etanercept · 1 trial · 1 indication

Phase 3 1
NCT01235442Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque PsoriasisPsoriasis
COMPLETED592 Analytics
PHASE3COMPLETED
Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

PASI 75 at Week 12
Week 12

The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.

Secondary Endpoints

sPGA (0,1) at Week 12
Week 12
PASI 90 at Week 12
Week 12
Patient Satisfaction at Week 12
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
etanercept and clobetasolEXPERIMENTALEtanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)
etanerceptEXPERIMENTALEtanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks

Interventions

NameTypeDescription
1=EtanerceptDRUG50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.
2=Clobetasol propionate foamDRUG0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has had stable moderate to severe plaque psoriasis for at least 6 months * Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline. * Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator Exclusion Criteria: ...

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Frequently asked questions about 1=Etanercept

What is Etanercept used for in psoriasis?

Etanercept is used for the treatment of moderate to severe plaque psoriasis. It is being investigated as a topical therapy combined with etanercept in a Phase 3 clinical trial. The study enrolled 592 participants aged 18 years and older with psoriasis.

Who makes Etanercept?

Etanercept is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the efficacy and safety of etanercept for the treatment of moderate to severe plaque psoriasis.

What phase is Etanercept in for psoriasis?

Etanercept is in Phase 3 clinical development for the treatment of moderate to severe plaque psoriasis. The Phase 3 trial has been completed, with a total enrollment of 592 participants. Etanercept remains an investigational drug for this indication and is not yet approved.

What clinical trials is Etanercept in?

Etanercept is associated with one completed Phase 3 clinical trial registered as NCT01235442. The trial, titled 'Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis,' enrolled 592 participants and was a controlled, randomized study.

Is Etanercept a small molecule?

Yes, Etanercept is classified as a small molecule therapeutic. It is being studied in the dermatology therapeutic area for the treatment of psoriasis. The Phase 3 clinical trial evaluating etanercept was a controlled study with 592 enrolled participants.