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Humira

Phase 3

Psoriasis | Monoclonal antibody | Dermatology |Abbott Laboratories|Last Updated: Apr 11, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment203

FDA Designations

No designations recorded

Clinical trial landscape

Humira · 1 trial · 1 indication

Phase 3 1
NCT00513370A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of PsoriasisPsoriasis
COMPLETED203 Analytics
PHASE3COMPLETED
A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks
16 weeks

PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

Secondary Endpoints

Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks
16 and 24 weeks
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks
16 and 24 weeks
Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)
16 and 24 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Humira (adalimumab)BIOLOGICALStudy drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Subject has a clinical diagnosis of psoriasis for at least 6 months prior to the Screening, as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator * Subject must have stable plaque psoriasis ...

Countries:Canada
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Frequently asked questions about Humira

What is Humira used for in psoriasis?

Humira is a monoclonal antibody used for the treatment of psoriasis. It is being developed by Abbott Laboratories for this dermatological condition. In clinical trials, Humira has been studied as an add-on therapy for patients with psoriasis who have had an inadequate response to their current treatment.

What does Humira target?

Humira is a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-alpha). By binding to TNF-alpha, Humira is designed to block its activity, which is involved in the inflammatory process of psoriasis. This mechanism is intended to reduce the signs and symptoms of the condition.

Who makes Humira?

Humira is developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The company is conducting clinical research on Humira for the treatment of psoriasis, with a completed Phase 3 trial evaluating its use in this indication.

What phase is Humira in for psoriasis?

Humira is in Phase 3 clinical development for the treatment of psoriasis. A Phase 3 trial, identified as NCT00513370, has been completed. This trial was an open-label, uncontrolled study that enrolled 203 participants in Canada. Humira is still considered investigational for this use.

What clinical trials is Humira in for psoriasis?

Humira has one completed clinical trial for psoriasis, registered as NCT00513370. This Phase 3 study was titled "A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis." The trial enrolled 203 adults aged 18 years and older in Canada.

Is Humira the same as adalimumab?

Yes, Humira is the same as adalimumab. The clinical trial for Humira in psoriasis, NCT00513370, specifically evaluates adalimumab, which is the scientific name for Humira. This alternative name is used in the trial title and is important for identifying the drug in medical literature.