Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: PF-06700841; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02969018

B7931004

2016-004049-96 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.

Enrollment: 212 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
• Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
• Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion criteria

• Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
• Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
• Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
• Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
• Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
• Have undergone treatment with tofacitinib within 3 months of first dose.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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212 participants in 8 patient groups, including a placebo group

PF-06700841 60 mg followed by 30 mg once daily

Experimental group

Description:

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 30 mg PF-06700841 once daily

Treatment:

Drug: PF-06700841

PF-06700841 60 mg followed by 10 mg once daily

Experimental group

Description:

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

Treatment:

Drug: PF-06700841

PF-06700841 60mg once daily followed by 100mg once weekly

Experimental group

Description:

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

Treatment:

Drug: PF-06700841

PF-06700841 60mg once daily followed by placebo once daily

Experimental group

Description:

4 week induction with 60 mg PF-06700841 once daily, followed by 8 week chronic administration of placebo once daily

Treatment:

Drug: PF-06700841

PF-06700841 30mg once daily

Experimental group

Description:

4 week induction with 30 mg PF-06700841 once daily followed by 8 week chronic administration of 30 mg PF-06700841 once daily

Treatment:

Drug: PF-06700841

PF-06700841 30mg once daily followed by 10mg once daily

Experimental group

Description:

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 10 mg PF-06700841 once daily

Treatment:

Drug: PF-06700841

PF-06700841 30mg once daily followed by 100mg once weekly

Experimental group

Description:

4 week induction with 30 mg PF-06700841 once daily, followed by 8 week chronic administration of 100 mg PF-06700841 once weekly

Treatment:

Drug: PF-06700841

Placebo

Placebo Comparator group

Description:

12 weeks once daily placebo

Treatment:

Other: Placebo