Phase 2
Completed N=212
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02969018 ↗Enrolled (actual)
212
Serious AEs
2.4%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 — -15.85; -10.56; -14.28; -10.14 units on a scale — p=0.0005
Summary
The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
-15.85; -10.56; -14.28; -10.14; -17.28; -13.27 | 0.0005 sig |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 |
60.0; 24.1; 57.7; 24.0; 86.2; 24.0 | — |
| SECONDARY Change From Baseline in PASI Scores at Week 4 by Induction Dose |
-13.17; -12.16; -4.17 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16 |
0; 6.9; 7.7; 4.0; 0; 4.0 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 |
12.0; 13.8; 19.2; 20.0; 10.3; 8.0 | — |
| SECONDARY Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 |
0; 3.4; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16 |
-5.74; -4.60; -5.85; -5.37; -3.97; -4.41 | — |
| SECONDARY Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 |
-26.70; -24.66; -30.25; -23.33; -20.92; -17.50 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
19; 21; 18; 18; 21; 16 | — |
| SECONDARY Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs |
2; 4; 1; 2; 0; 2 | — |
| SECONDARY Change From Baseline in Blood Lipid Level at Weeks 4 and 12 |
15.91; 11.27; 15.00; 15.88; 8.96; -2.21 | — |
| SECONDARY Number of Participants With Any Post-Baseline Laboratory Test Abnormalities |
17; 20; 20; 16; 21; 20 | — |
| SECONDARY Number of Participants With Post-Baseline Vital Sign Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities |
0; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02969018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.