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Janus Kinase (JAK) Inhibitor
Ritlecitinib for Alopecia Areata (Allegro2a Trial)
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis
Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 9 (month 6 for the 2 participants who entered the active therapy extension phase at month 6). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Awards & highlights
Allegro2a Trial Summary
This trial is testing a new drug to treat hair loss in adults aged 18-50 due to Alopecia Areata. The trial is evaluating the safety and tolerability of the drug.
Who is the study for?
Adults aged 18 to ≤50 with Alopecia Areata, including alopecia totalis and universalis, who have lost at least 25% of scalp hair. Participants must have stable health conditions, normal neurological exams (except for certain neuropathies), normal hearing, and no significant medical issues or recent serious infections.Check my eligibility
What is being tested?
The trial is testing the safety of a drug called ritlecitinib (PF-06651600) compared to a placebo in treating hair loss from Alopecia Areata. It's a global Phase 2a study where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects may include reactions specific to ritlecitinib but are not detailed here. Common side effects could range from mild skin irritation at the application site to more systemic responses depending on how the body reacts to new medication.
Allegro2a Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a form of severe hair loss.
Select...
I have been diagnosed with a form of severe hair loss.
Select...
My hearing and brainstem auditory tests are normal.
Select...
I have lost at least 25% of my hair due to alopecia areata.
Allegro2a Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 9 (month 6 for the 2 participants who entered the active therapy extension phase at month 6). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 9 (month 6 for the 2 participants who entered the active therapy extension phase at month 6). baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9
Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9
Secondary outcome measures
Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9
Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9
+14 moreSide effects data
From 2022 Phase 2 trial • 460 Patients • NCT044136177%
SARS-CoV-2 test positive
5%
Urinary tract infection
4%
Nausea
4%
Headache
3%
Nasopharyngitis
3%
Arthralgia
3%
Rheumatoid arthritis
1%
Coronavirus infection
1%
Skin squamous cell carcinoma recurrent
1%
Uterine leiomyoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 11mg MR
PF-06651600 100mg
PF-06650833 400mg MR
PF-06650833 400mg MR + Tofacitinib 11mg MR
PF-06650833 400mg MR + PF-06651600 100mg
Allegro2a Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Arm: PF-06651600Experimental Treatment1 Intervention
ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
Group II: Control Arm (Placebo) followed by active therapy extensionExperimental Treatment1 Intervention
matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
PF-06651600
2019
Completed Phase 2
~1900
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,803 Total Patients Enrolled
13 Trials studying Alopecia Areata
85,963 Patients Enrolled for Alopecia Areata
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,971 Total Patients Enrolled
6 Trials studying Alopecia Areata
2,856 Patients Enrolled for Alopecia Areata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a serious infection or needed IV antibiotics in the last 6 months.You have been exposed to loud noise at work or during activities.Your HbA1c level is higher than 7.5% at the time of screening.My other medications have not changed recently and won't change during the study.I am not taking any medications that could cause nerve damage or hearing loss.I have active or untreated hepatitis.I have been diagnosed with a form of severe hair loss.You have abnormal results in specific lab tests required for this study.I have been diagnosed with a form of severe hair loss.My neurological exam is normal, but I may have a stable nerve issue in my arm.My hearing and brainstem auditory tests are normal.I or a close family member have had issues with nerve damage.I have had shingles more than once or it has spread in my body.I have active or untreated latent TB.I have lost at least 25% of my hair due to alopecia areata.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm: PF-06651600
- Group 2: Control Arm (Placebo) followed by active therapy extension
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT04517864 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join this medical investigation?
"Currently, this trial is not open for enrollment. Originally posted on September 15th 2020 and last modified on August 26th 2022, other studies focusing on alopecia areata have 85 available openings while 3 spots remain vacant in the PF-06651600 research initiative."
Answered by AI
To what degree can PF-06651600 be detrimental to one's health?
"The safety of the drug PF-06651600 is rated as 2 on a scale from 1 to 3, since it has been through Phase 2 trials and there are some data points supporting its safety but none proving efficacy."
Answered by AI
What is the upper bound of participants for this experiment?
"Patient recruitment for this trial has concluded. Originally posted on September 15th 2020, the clinical trial was last updated August 26th 2022. For those searching alternative trials, there are 85 studies related to alopecia areata and 3 investigations recruiting participants with PF-06651600 still available."
Answered by AI
Has PF-06651600 been previously tested in any other clinical research studies?
"In 2018, the initial PF-06651600 study began at Universitaetsklinikum Schleswig-Holstein. As of now, 18346 trials have been concluded and there are presently 3 studies in progress. A considerable number of these tests take place within Orlando, Illinois."
Answered by AI
In what regions is this research endeavor being conducted?
"As of now, the trial is running in 30 different sites across the nation, such as Orlando, Skokie and Albuquerque. To reduce travel requirements while participating in this study it might be most opportune to select a location closeby."
Answered by AI
Do participants of this research study need to be under 55 years old?
"This research trial is open to anyone aged 18 and above, but no older than 50."
Answered by AI
Are there any limitations or restrictions for individuals to join this clinical exploration?
"Patient qualification for this specific trial requires a diagnosis of alopecia areata and an age range between 18-50. If these criteria are met, enrolment is possible; the maximum number of participants being 71."
Answered by AI
Is this research project an unprecedented endeavor?
"Since 2018, Pfizer has sponsored multiple clinical trials researching the efficacy of PF-06651600. After initial testing with 246 patients obtained Phase 2 approval in 2018, there are currently 3 active studies running across 139 cities and 34 nations."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Georgia
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Kendall Adkisson, MD - Intracoastal Dermatology
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Other
Skin Care Research, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
Hair lost condition. I am looking for help with hair loss. I’ve been trying everything, and it seems to be getting worse and worse.
PatientReceived no prior treatments
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