A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.

Roche

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: RG3421 120mg; Drug: RG3421 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504270

NS20454

Details and patient eligibility

About

This study will investigate the safety, efficacy and pharmacokinetics of R3421 in patients with moderate to severe chronic plaque psoriasis. Patients will be randomized to one of 3 treatment groups to receive once daily oral treatment with a)R3421 20mg, b)R3421 120mg, or c)placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-70 years of age;
• medically stable, moderate to severe chronic plaque psoriasis.

Exclusion criteria

• any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions;
• confounding or concomitant condition or treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

po daily

Treatment:

Drug: Placebo

RG3421 120mg

Experimental group

Description:

120mg po daily

Treatment:

Drug: RG3421 120mg

RG3421 20mg

Experimental group

Description:

20mg po daily

Treatment:

Drug: RG3421 20mg