Phase 2
Completed N=267
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Source: ClinicalTrials.gov NCT02780167 ↗Enrolled (actual)
267
Serious AEs
3.4%
Results posted
May 2018
Primary outcomePrimary: Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 — 6.3; 8.2; 12.3; 27.8 percentage of participants — p=0.1210
Summary
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12 |
6.3; 8.2; 12.3; 27.8; 44.5 | 0.1210 |
| SECONDARY Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12 |
-35.22; -31.13; -40.73; -59.04; -82.57 | 0.6731 |
| SECONDARY Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12 |
0.0; 2.1; 2.0; 1.8; 3.7; 3.6 | — |
| SECONDARY Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points |
1.9; 4.2; 6.1; 5.5; 9.4; 7.3 | — |
| SECONDARY Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12. |
-12.28; -13.80; -14.85; -19.85; -41.26; -23.54 | — |
| SECONDARY Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points |
4.0; 6.7; 17.0; 14.8; 17.0; 8.0 | — |
| SECONDARY Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points |
2.0; 2.2; 6.5; 10.0; 15.2; 0.0 | — |
| SECONDARY Time to Achieving >=3 Points Improvement in NRS |
30.0; 43.0; 12.0; 9.0; 7.0; 29.0 | — |
| SECONDARY Time to Achieving >=4 Points Improvement in NRS |
78.0; NA; 43.0; 14.0; 10.0; 59.0 | — |
| SECONDARY Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points |
0.56; -1.51; -9.39; -10.06; -6.79; -1.32 | — |
| SECONDARY Change From Baseline in Pruritus NRS Score at All Scheduled Time Points |
-0.08; -0.20; -0.83; -0.85; -1.00; -0.22 | — |
| SECONDARY Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points |
9.3; 8.3; 14.0; 12.7; 40.7; 27.3 | — |
| SECONDARY Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points |
3.7; 2.1; 6.0; 3.6; 16.7; 5.5 | — |
| SECONDARY Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points |
0.0; 2.1; 4.0; 0.0; 7.4; 0.0 | — |
| SECONDARY Change From Baseline in Affected BSA at All Scheduled Time Points |
-0.06; -3.76; -2.45; -4.63; -10.86; -5.43 | — |
| SECONDARY Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points |
-7.910; -5.000; -8.388; -12.024; -21.326; -10.905 | — |
| SECONDARY Percent Change From Baseline in SCORAD at All Scheduled Time Points |
-11.547; -7.287; -13.068; -19.185; -34.660; -16.488 | — |
| SECONDARY Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points |
3.7; 2.1; 6.0; 7.3; 29.6; 5.5 | — |
| SECONDARY Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points |
0.0; 2.1; 2.0; 1.8; 3.7; 0.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
32; 34; 34; 43; 41 | — |
| SECONDARY Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points |
0.0; 2.1; 4.1; 1.9; 16.7; 5.6 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points |
-1.4; -1.4; -3.4; -5.1; -6.3; -2.3 | — |
| SECONDARY Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points |
-1.1; -0.6; -2.1; -3.9; -9.2; -2.2 | — |
| SECONDARY Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points |
-0.5; 0.0; -0.6; -0.9; -1.0; -0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- Must have the following atopic dermatitis criteria:
- Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
- Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
- Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).
Exclusion Criteria
- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- Infected with hepatitis B or hepatitis C viruses.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Have received any of the following treatment regiments specified in the timeframes outlined below:
Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
Data sourced from ClinicalTrials.gov (NCT02780167). 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.