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Raptiva

Phase 3

Psoriasis | Small molecule | Dermatology |Roche Holding AG|Last Updated: Mar 20, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment1,136

FDA Designations

No designations recorded

Clinical trial landscape

Raptiva · 4 trials · 2 indications

Phase 3 3Phase 1 1
NCT00096603A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600gPsoriasis
COMPLETED450 Analytics
NCT00109317A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic TherapyPsoriasis
COMPLETED686 Analytics
NCT00109252A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390gPsoriasis
COMPLETED- Analytics
PHASE3COMPLETED
A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g
PsoriasisUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
PsoriasisUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C
Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C.

Secondary Endpoints

Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Characterization of mean anti-<phi>X174 concentrations 2 and 4 weeks after the first and 2 and 4 weeks after the second <phi>X174 vaccinations during efalizumab treatment (Group A) compared with placebo (Group C)
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Study Design & Arms

MaskingNONE
PurposeTREATMENT

Interventions

NameTypeDescription
Raptiva (efalizumab)DRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed informed consent * Previous participation in Study ACD2600g * For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study Exclusion Criteria: * Any medical condition that, in the judgment of the investigato...

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Frequently asked questions about Raptiva

What is Raptiva used for?

Raptiva is an investigational small molecule being developed for the treatment of psoriasis, specifically plaque psoriasis, in the dermatology therapeutic area. It is being studied in adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Who makes Raptiva?

Raptiva is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of Raptiva in patients with psoriasis and plaque psoriasis.

What phase is Raptiva in?

Raptiva is in Phase 1 clinical development. While some completed trials were Phase 3, the current development stage is Phase 1, and it remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is Raptiva in?

Raptiva has been studied in three completed trials: NCT00096603, NCT00109252, and NCT00109317, all in Phase 3 for psoriasis. Additionally, NCT00382512 is a Phase 1 trial in plaque psoriasis. All trials are completed, with a total enrollment of 1,136 participants.

Is Raptiva the same as efalizumab?

Yes, Raptiva is also known as efalizumab. One of its clinical trials, NCT00382512, specifically evaluates the effects of efalizumab on immune responses in subjects with moderate plaque psoriasis, confirming that Raptiva and efalizumab refer to the same drug.