Phase 2
Completed N=294
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Source: ClinicalTrials.gov NCT03850483 ↗Enrolled (actual)
294
Serious AEs
1.8%
Results posted
Jun 2022
Primary outcomePrimary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 — -1.6; -2.2; -1.4; -2.2 Unit on a scale — p=0.1641
Summary
This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 280 participants are planned to be randomized into the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 |
-1.6; -2.2; -1.4; -2.2; -2.4; -2.2 | 0.1641 |
| SECONDARY Percentage of Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12 |
6.9; 10.3; 15.4; 10.3; 21.4; 14.7 | 0.3747 |
| SECONDARY Percentage of Participants With 75% Reduction From Baseline in PASI at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
3.1; 3.0; 0; 0; 0; 0 | 0.4225 |
| SECONDARY Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 |
-0.9; -0.7; -0.6; -0.9; -0.8; -0.5 | 0.8038 |
| SECONDARY Change From Baseline in PASI Scores at Week 14 and 16 |
6.12; 7.19; 6.46; 6.63; 6.83; 6.08 | — |
| SECONDARY Percent Change From Baseline in PASI Scores at Week 1, 2, 4, 6, 8, 10 and 12 |
-15.5; -12.9; -8.2; -10.4; -13.0; -7.4 | 0.6917 |
| SECONDARY Percent Change From Baseline in PASI Scores at Week 14 and 16 |
6.12; 7.19; 6.46; 6.63; 6.83; 6.08 | — |
| SECONDARY Absolute Peak-Pruritus Numerical Rating Scale (PP-NRS) Score at Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
4.6; 4.4; 4.5; 4.1; 4.5; 4.9 | 0.3279 |
| SECONDARY Absolute PP-NRS Score at Week 14 and 16 |
5.2; 2.6; 2.8; 2.4; 3.2; 4.0 | — |
| SECONDARY Change From Baseline in PP-NRS Score at Week 1, 2, 4, 6, 8, 10 and 12 |
-0.4; -0.6; -0.9; -0.9; -0.9; -0.9 | 0.3232 |
| SECONDARY Change From Baseline in PP-NRS Score at Week 14 and 16 |
-0.4; -1.4; -1.8; -1.2; -1.1; -1.0 | — |
| SECONDARY Absolute Psoriasis Symptom Inventory (PSI) Score at Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, Early Termination (ET), ET Follow-up Visit 1 and 2 |
14.2; 12.3; 13.2; 10.3; 12.3; 14.0 | — |
| SECONDARY Change From Baseline in PSI Score at Week 1, 2, 4, 6, 8, 10, 12, 14 and 16, ET, ET Follow-up Visit 1 and 2 |
-3.3; -2.8; -3.0; -2.6; -3.4; -3.9 | — |
| SECONDARY Percentage of Participants With PGA Score Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 1, 2, 4, 6, 8, 10, 14, and 16 |
2.8; 2.7; 2.7; 0; 0; 0 | 0.4216 |
| SECONDARY Percentage of Participants Who Achieved PSI Score of 0 (Not at All) or 1 (Mild) on All Items at Week 1, 2, 4, 6, 8, 10, 12, 14, and 16 |
5.7; 19.4; 11.8; 22.2; 13.5; 19.1 | 0.0544 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and SAEs |
17; 16; 14; 17; 14; 20 | — |
| SECONDARY Number of Participants With TEAEs by Severity |
12; 9; 11; 11; 7; 8 | — |
| SECONDARY Number of Participants Who Discontinued From Study Due to Adverse Events |
1; 1; 3; 0; 2; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities Meeting Specified Criteria |
7; 6; 11; 7; 5; 12 | — |
| SECONDARY Number of Participants With Categorical Summary of Post-Baseline Electrocardiogram (ECG) Data |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Classified Per Skin Tolerability Assessment Severity Grades on Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 |
36; 37; 36; 36; 36; 48 | — |
Eligibility Criteria
Inclusion Criteria
- plaque psoriasis for 6 months
- PGA score mild or moderate
- body surface area (BSA) 2-15%
Exclusion Criteria
- other skin conditions that would interfere with the evaluation of psoriasis
- history of herpes zoster or simplex
- Infected with Mycobacterium tuberculosis
Data sourced from ClinicalTrials.gov (NCT03850483). 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.