PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

• ClinicalTrials.gov Identifier: NCT03732807
• Recruitment Status: Completed
• First Posted: November 7, 2018
• Results First Posted: February 24, 2022
• Last Update Posted: February 24, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 5, 2018
• First Posted Date: November 7, 2018
• Results First Submitted Date: December 16, 2021
• Results First Posted Date: February 24, 2022
• Last Update Posted Date: February 24, 2022
• Actual Study Start Date: December 3, 2018
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 16, 2021)

Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24 [ Time Frame: Week 24 ]

SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (<=) 20 at week 24 were reported.

Original Primary Outcome Measures (submitted: November 5, 2018)

Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) Score <=10 [ Time Frame: Week 24 ]

Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.

Current Secondary Outcome Measures (submitted: December 16, 2021)

• Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4 [ Time Frame: Week 24 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
• Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1 [ Time Frame: Week 24 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <= 10 at week 24 were reported.
• Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24 [ Time Frame: Week 24 ]
  PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
• 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 [ Time Frame: Week 24 ]
  The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=20 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=20 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
• 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 [ Time Frame: Week 24 ]
  The exposure response of Ritlecitinib (PF-06651600) on the regrowth of scalp hair was characterized using a Bayesian three-parameter hyperbolic Emax model for the SALT score <=10 at Week 24 with an additional term for effect of loading dose. In Emax exposure-response model the response function was the log odds of the percentage of participants with response based on SALT <=10 at Week 24, which was fit on the logistic scale and then back-transformed to percentage. The effect of loading dose is included as fixed factor in the model. The variable that represents loading dose has values of 1 for groups 200/50 mg once daily and 200/30 mg once daily and of 0 for the remaining groups. SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
• 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 [ Time Frame: Week 4, 8, 12, 18, 28, 34, 40, and 48 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease.
• 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 [ Time Frame: Week 4, 8, 12, 18, 28, 34, 40, and 48 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score <=10 were reported.
• 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 [ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. A SALT 75 response was a 75% or greater reduction from baseline in SALT score.
• Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, 18, and 24 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
• Change From Baseline in SALT Score at Week 28, 34, 40, and 48 [ Time Frame: Baseline (Day 1), Week 28, 34, 40, and 48 ]
  SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. Baseline was defined as pre-dose on Day 1.
• 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 [ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0= no eyebrow, 1=minimal eyebrow, 2=moderate eyebrow and 3= normal eyebrow, where higher scores represent less hair loss of eyebrows.
• 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 [ Time Frame: Week 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal), where, 0=no eyelash, 1=minimal eyelash, 2=moderate eyelash and 3=normal eyelash, where higher scores represent less hair loss of eyelash.
• 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 [ Time Frame: Week 4, 8, 12, 18, 24, 34, 40, and 48 ]
  PGI-C is a self-administered questionnaire to evaluate the improvement or worsening of participant's AA as compared to the start of the study. PGI-C was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGI-C scores as follows: 1=greatly improved, 2=moderately improved, 3=slightly improved, 4=not changed, 5=slightly worsened, 6=moderately worsened and 7=greatly worsened.
• 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 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, 18, and 24 ]
  AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
• Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations [ Time Frame: Baseline (Day 1), Week 34, 40, and 48 ]
  AAPPO scale is 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over past week. Items 1-4 assessed current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss'. Items 5-8 assessed emotional symptoms. Response choices on these items were scored from 0 ='never' to 4='always'. Items 9-11 assessed activity limitations. Response choices on these items were scored from 0='not at all' to 4='completely'. Change from baseline in AAPPO emotional symptoms sub score were calculated as mean of items 5-8 and ranged from 0(never) to 4(always), where higher scores indicated more emotional symptoms. Change from baseline in AAPPO activity limitations sub score was calculated as mean of items 9-11 and ranged from 0(not at all) to 4(completely), where higher scores indicated more activity limitations. Baseline was defined as pre-dose on Day 1.
• 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 [ Time Frame: Week 4, 8, 12, 18, 24, 34, 40, and 48 ]
  AAPPO scale is a 11-item self-administered questionnaire that measured hair loss, emotional symptoms, and activity limitations over the past week. Items 1-4 were to assess the current hair loss, eyebrow loss, eyelash loss and body hair loss and were analyzed separately on a scale of 0-4, with 0 ='no hair loss' and 4='complete hair loss', where higher scores indicated more hair loss.

Original Secondary Outcome Measures (submitted: November 5, 2018)

• Characterize exposure response on the percentage of subjects achieving an absolute SALT score <=10 [ Time Frame: Week 24 ]
  Exposure response will be characterized using a Bayesian three-parameter exposure response model.
• Percentage of subjects achieving a SALT score of <=10 [ Time Frame: Weeks 4, 8, 12, 18, 28, 34, 40, and 48 ]
  Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
• Percentage of subjects achieving a 50% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
• Percentage of subjects achieving a 75% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
• Percentage of subjects achieving a 90% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
• Absolute SALT scores [ Time Frame: Baseline, Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
• Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  The eyebrow assessment (EBA) is an numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
• Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
  The eyelash assessment (ELA) is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
• Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) scale scores [ Time Frame: Weeks 4, 8, 12, 18, 24, 34, 40, and 48 ]
  The Alopecia Areata Patient Priority Outcomes (AAPPO) scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.
• Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
  HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
• Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
  HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
• Change from baseline in 36 Item Short Form Health Survey version 2 Acute (SF36v2 Acute) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
  36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS).

Current Other Pre-specified Outcome Measures (submitted: December 16, 2021)

• Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]
  HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
• Change From Baseline in Depression Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 [ Time Frame: Baseline (Day 1), Week 48 ]
  HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms. Baseline was defined as pre-dose on Day 1.
• Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Weeks 4, 8, 12, and 24 [ Time Frame: Baseline (Day 1), Week 4, 8, 12, and 24 ]
  HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
• Change From Baseline in Anxiety Subscale Score of Hospital Anxiety and Depression Scale (HADS) at Week 48 [ Time Frame: Baseline (Day 1), Week 48 ]
  HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms. Baseline was defined as pre-dose on Day 1.
• Percentage of Participants With a Baseline Score Indicative of Depression Achieving Normal Depression Subscale Score of HADS at Week 4, 8, 12, 24, and 48 [ Time Frame: Week 4, 8, 12, 24 and 48 ]
  HADS is a validated 14-item PRO measure used to assess states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for depression subscale; higher score indicating greater severity of depression symptoms.
• Percentage of Participants With a Baseline Score Indicative of Anxiety Achieving Normal Anxiety Subscale Score of HADS at Week 4, 8, 12, 24, and 48 [ Time Frame: Week 4, 8, 12, 24 and 48 ]
  HADS is a validated 14-item PRO measure used to assessed states of anxiety and depression over the past week. Items were rated on a 4-point severity scale. The HADS produces 2 scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states with established normal score cut-offs. The instrument have been validated for use by adolescents aged 12 and older. Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for anxiety subscale; higher score indicating greater severity of anxiety symptoms.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PF-06651600 for the Treatment of Alopecia Areata
• Official Title: A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alopecia Areata

Intervention

• Drug: PF-06651600 Induction Dose
  Oral tablets taken once daily (QD)
• Drug: PF-06651600 Maintenance Dose #1
  Oral tablets taken QD
• Drug: PF-06651600 Maintenance Dose #2
  Oral tablets taken QD
• Drug: PF-06651600 Maintenance Dose #3
  Oral tablets taken QD
• Drug: Placebo
  Oral tablets taken QD

Study Arms

• Experimental: Sequence A
  Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
  Interventions:

  • Drug: PF-06651600 Induction Dose
  • Drug: PF-06651600 Maintenance Dose #1
• Experimental: Sequence B
  Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
  Interventions:

  • Drug: PF-06651600 Induction Dose
  • Drug: PF-06651600 Maintenance Dose #2
• Experimental: Sequence C
  Maintenance dose #1 given QD for 48 weeks
  Intervention: Drug: PF-06651600 Maintenance Dose #1
• Experimental: Sequence D
  Maintenance dose #2 given QD for 48 weeks
  Intervention: Drug: PF-06651600 Maintenance Dose #2
• Experimental: Sequence E
  Maintenance dose #3 given QD for 48 weeks
  Intervention: Drug: PF-06651600 Maintenance Dose #3
• Experimental: Sequence F
  Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
  Interventions:

  • Drug: PF-06651600 Induction Dose
  • Drug: PF-06651600 Maintenance Dose #1
  • Drug: Placebo
• Experimental: Sequence G
  Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
  Interventions:

  • Drug: PF-06651600 Maintenance Dose #1
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2021): 718
• Original Estimated Enrollment (submitted: November 5, 2018): 660
• Actual Study Completion Date: June 24, 2021
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States
• Removed Location Countries: Puerto Rico, Singapore

Administrative Information

• NCT Number: NCT03732807
• Other Study ID Numbers: B7981015; 2018-001714-14 ( EudraCT Number ); ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2022