Phase 3
N=718
PF-06651600 for the Treatment of Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03732807 ↗Enrolled (actual)
718
Serious AEs
2.0%
Results posted
Feb 2022
Primary outcome: Primary: Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 — 30.65; 22.31; 23.39; 14.29 Percentage of participants — p=<0.000001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PF-06651600 Induction Dose (Drug); PF-06651600 Maintenance Dose #1 (Drug); PF-06651600 Maintenance Dose #2 (Drug); PF-06651600 Maintenance Dose #3 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 |
30.65; 22.31; 23.39; 14.29; 1.69; 1.54 | <0.000001 sig |
| SECONDARY Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 |
21.29; 12.87; 13.42; 10.62; 1.65; 1.54 | <0.000001 sig |
| SECONDARY Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 |
21.77; 13.22; 13.71; 10.92; 1.69; 1.54 | <0.000001 sig |
| SECONDARY Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 |
52.19; 45.40; 49.17; 41.95; 11.36; 9.23 | <0.000001 sig |
| SECONDARY Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model |
32.37; 20.57; 22.52; 13.58; 4.81; 1.63 | — |
| SECONDARY Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model |
21.29; 13.76; 14.43; 9.02; 3.88; 1.66 | — |
| SECONDARY Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48 |
0.78; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48 |
0.78; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
0.78; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 |
-2.3; -2.7; -1.8; -1.3; -1.3; -0.9 | — |
| SECONDARY Change From Baseline in SALT Score at Week 28, 34, 40, and 48 |
90.3; 90.5; 90.3; 90.0; 88.3; 94.4 | — |
| SECONDARY Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
1.87; 2.88; 0.00; 0.93; 1.96; 0.00 | — |
| SECONDARY Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 |
3.03; 1.08; 5.38; 1.03; 4.55; 2.04 | — |
| SECONDARY Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48 |
5.43; 4.03; 2.36; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations |
-0.37; -0.22; -0.33; -0.31; -0.29; -0.28 | — |
| SECONDARY Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations |
-0.78; -0.72; -0.72; -0.71; -0.62; -0.77 | — |
| SECONDARY Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48 |
11.38; 9.76; 4.17; 4.84; 1.69; 6.35 | — |
Summary
This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of alopecia areata with no other cause of hair loss
- ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
- Current episode of hair loss ≤10 years
Exclusion Criteria
- Other types of alopecia or other diseases that can cause hair loss
- Other scalp diseases that could interfere with assessment of hair loss/regrowth
- Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
- Any previous use of any Janus kinase (JAK) inhibitor
Data sourced from ClinicalTrials.gov (NCT03732807). 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.