PF-06651600 for Alopecia Areata

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hospital Universitario La Paz: Servicio de Farmacia, Madrid, Spain
Alopecia Areata+1 More
PF-06651600 - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

Long-Term PF-06651600 for the Treatment of Alopecia Areata

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Eligible Conditions

  • Alopecia Areata

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Alopecia Areata

Study Objectives

This trial is evaluating whether PF-06651600 will improve 1 primary outcome and 28 secondary outcomes in patients with Alopecia Areata. Measurement will happen over the course of Vaccine sub-study Day 1 and Month 1.

Month 60
Number of subjects reporting adverse events leading to discontinuation
Number of subjects reporting serious adverse events
Number of subjects reporting treatment-emergent adverse events
Number of subjects with clinically significant abnormalities in clinical laboratory values
Number of subjects with clinically significant abnormalities in vital signs
Month 1
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score
Month 1
Change from baseline in SALT score
Percentage of subjects with a 75% improvement in SALT score from baseline
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20
Month 1
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains
Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS)
Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS)
Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety
Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression
Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved"
Month 1
Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C
Vaccine sub-study Month 1
Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values
Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels
Vaccine sub-study: Number of subjects reporting adverse events
Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation
Vaccine sub-study: Number of subjects reporting serious adverse events
Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response
Vaccine sub-study: Percentage of subjects with a tetanus booster response
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL
Vaccine sub-study: Percentage of subjects with ≥1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C
Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Alopecia Areata

Trial Design

2 Treatment Groups

Treatment sequence 2
1 of 2
Treatment sequence 1
1 of 2
Experimental Treatment

This trial requires 1050 total participants across 2 different treatment groups

This trial involves 2 different treatments. PF-06651600 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Treatment sequence 2Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment sequence 1Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 tablet or capsule given QD for 59 months. Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 56 visit of the main B7981032 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06651600
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 for reporting.

Closest Location

Schweiger Dermatology Group - Verona, NJ

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received newly diagnosed for Alopecia Areata or the other condition listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
No evidence of terminal scalp hair regrowth within 6 months (de novo only)
Current episode of terminal scalp hair loss <=10 years (de novo only)
Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis

Patient Q&A Section

What are common treatments for alopecia?

"There are many treatments for alopecia that can decrease, halt or reverse the signs and symptoms. Treatments such as hair transplants can be used to restore hair to a healthier appearance." - Anonymous Online Contributor

Unverified Answer

Can alopecia be cured?

"Although there is no cure, the use of products such as sulfasalazine, minoxidil or finasteride may decrease hair loss as a result of alopecia. Finasteride can help some patients with peribulbar skin tags, but not alopecia." - Anonymous Online Contributor

Unverified Answer

How many people get alopecia a year in the United States?

"Around 30.2 millions suffer from female pattern hair loss in the United States. According to the 2010 National Health Interview Survey, around 21.7 million individuals are affected by female pattern hair loss in the United States." - Anonymous Online Contributor

Unverified Answer

What is alopecia?

"Alopecia is a condition that involves the permanent or temporary loss of hair from almost the whole body. It affects about one-third of men and the most commonly occurring is male pattern baldness. Alopecia affects about 18% of men. A survey of 3,731 men between the ages of 20 and 79 from four different counties revealed that the prevalence of alopecia is 7.3% and about half of the cases are male." - Anonymous Online Contributor

Unverified Answer

What are the signs of alopecia?

"Alopecia areata is characterized by the baldness of the scalp to the level of the eyebrows, which is associated with the loss of hair and skin on the sides of the head. Patients are usually asymptomatic other than the baldness which gives a sign that the condition is severe as the more scalp hair is lost, the less likely the patient will be symptomatic and less severe the alopecia.\n" - Anonymous Online Contributor

Unverified Answer

What causes alopecia?

"Alopecia is caused by different genetic, neurological and endocrine conditions, and some infections. To improve hair growth, it is important to find the cause. All patients with hair loss need to exclude other diseases or drug side effects, like hormonal imbalance, and to be monitored for hair loss." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating alopecia?

"This was a review of recent studies showing the potentiality of some compounds in growing the alopecia hair in patients with severe hair loss. Further studies need to be conducted, using this review as an impetus, but it is already important to know that this could be a potential treatment option." - Anonymous Online Contributor

Unverified Answer

What is the latest research for alopecia?

"This specialised journal, Moll Folligo, focuses on research into the cause, prevention, medical and cosmetic treatments for hair disorders. There are still many unanswered questions in the field of hair loss. It is not known whether there can be regenerating cells in the hair follicle." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pf-06651600?

"The adverse reactions reported in the studies for PF-06651600 were more similar to those reported in placebo-treated patients, but were generally mild and transient in most cases. A subset of patients experienced a worsening of hair loss after starting PF-06651600 treatment; patients with preexisting hair loss may be at increased risk for the development of such a worsening." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pf-06651600?

"Pf-0451600 showed strong antifibrotic effects in a subset of patients with scarring alopecia, although clinical effect is dependent on dose and duration. Further randomized, double-blinded, placebo-controlled trials are mandatory to establish safety and efficacy of this agent." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pf-06651600 for therapeutic use?

"At present, one of the most effective medicines to alleviate the symptoms of androgenic alopecia is finasteride. The most recent development in pf-06651600 is a new prodrug formulation, PF-06651600AA, which contains the same dose level as that of finasteride. Moreover, PF-06651600AA can be administrated via oral, intramuscular or transdermal routes, which can obviously improve the therapeutic effect. And PF-06651600AA has been shown to be effective in a mouse model, which may indicate that PF-06651600AA can be an effective and safe therapy for androgenic alopecia." - Anonymous Online Contributor

Unverified Answer

Does alopecia run in families?

"Alopecia is a remarkably complex genetic trait. Genetic factors play a major role in the aetiology of this condition. The inheritance in families with the same family history can be strongly suggestive of genetic susceptibility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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