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Raptiva

Phase 4

Psoriasis | Monoclonal antibody | Dermatology |Roche Holding AG|Trials Updated: Mar 20, 2014

Raptiva development status

Highest phase Phase 4 (NCT00336973)
Phase scored for RHHBYPhase 3
Registered trials 10 across 3 sponsors since Apr 2002

Raptiva target and mechanism

ModalityMonoclonal antibody

Also known as Raptiva (efalizumab), efalizumab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment2,396

FDA Designations

No designations recorded

Raptiva clinical trials

Raptiva · 5 trials · 2 indications

Phase 3 4Phase 1 1
NCT00338143A Study to Evaluate Efalizumab in Adults With Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic TherapiesPsoriasis
COMPLETED1,200 Analytics
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 Efalizumab in Adults With Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies
PsoriasisUnlock trial 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

PurposeTREATMENT

Interventions

NameTypeDescription
efalizumabDRUG -
Raptiva (efalizumab)DRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed informed consent * Plaque psoriasis covering \>=10% of total BSA * Plaque psoriasis diagnosed for at least 6 months * In the opinion of the investigator, a candidate for systemic therapy for psoriasis * 18-75 years old * Body weight \<=125 kg * For women of childbearing...

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Frequently asked questions about Raptiva

What is Raptiva used for?

Raptiva is a monoclonal antibody developed for the treatment of plaque psoriasis and psoriasis, a chronic inflammatory skin condition. It was studied in adults with moderate to severe plaque psoriasis, including patients who were candidates for systemic therapy. Raptiva is also known by its generic name, efalizumab.

Who makes Raptiva?

Raptiva is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trial program evaluating efalizumab in plaque psoriasis, including Phase 1 and Phase 3 studies conducted in adult patients with moderate to severe forms of the disease.

What phase is Raptiva in?

Raptiva is an investigational monoclonal antibody that has been studied in clinical development, with a Phase 1 trial and multiple Phase 3 trials in plaque psoriasis. All four listed trials are completed, and no trials are currently active. The program enrolled a total of 1,136 participants across its studies.

What clinical trials is Raptiva in?

Raptiva has been evaluated in completed trials including NCT00382512, a Phase 1 study of immune responses in moderate plaque psoriasis, and NCT00109317, a Phase 3 study in adults with moderate to severe plaque psoriasis. Additional completed Phase 3 trials include NCT00109252 and NCT00096603, which assessed Raptiva in previously enrolled psoriasis patients.

Is Raptiva the same as efalizumab?

Yes, Raptiva is the brand name for efalizumab, a monoclonal antibody. The two names refer to the same drug candidate, so searches for either Raptiva or efalizumab point to the same development program in plaque psoriasis and psoriasis led by Roche Holding AG.

How many patients were enrolled in Raptiva trials?

The Raptiva clinical program enrolled 1,136 participants across its completed trials. The largest study, NCT00109317, enrolled 686 adults with moderate to severe plaque psoriasis, while NCT00096603 enrolled 450 patients and NCT00382512 enrolled 60 participants. One Phase 3 trial, NCT00109252, listed zero enrollment.