Alopecia AreataPRESTONCT06531109
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
An observational study of Alopecia Areata, run by Pfizer at 70 sites in 6 countries.
Trial summary
Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Ritlecitinib
- How many people
- 450 participants
- Where
- 70 sitesin 6 countries
- Study dates
- 7 Aug 2024to 15 Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population eligible for enrollment includes any adult and adolescent patients aged ≥12 years diagnosed with AA who receive at least one dose of ritlecitinib and satisfy the inclusion and exclusion criteria. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study. It will be allowed to enroll patients with previous use of topical JAK inhibitors only if there was at least a 4-week wash-out period prior to Baseline Visit
Who may be able to join
- Male and female patients aged >12 years at baseline.
- Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
- Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.
Who cannot join
- Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium).
- Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
- Patients previously treated with ritlecitinib or other JAK inhibitors.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
Trial locations and contacts
70 sites in 6 countries.
70 sites in 6 countries
United States28 sites
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dermatology of Boca
Boca Raton, Florida, 33431
Brigham & Women's Hospital/Harvard Medical School
Boston, Massachusetts, 02115
Raven Clinical Reseach
Burlington, Wisconsin, 53105
Pediatric Skin Research,LLC
Coral Gables, Florida, 33146
Raven Clinical Reseach
Fairfax, Virginia, 22033
CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
Fremont, California, 94538
Rao Dermatology
Fresno, California, 93720
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, 37072
Hickory Dermatology Research Center
Hickory, North Carolina, 28602
University of Iowa Health Care
Iowa City, Iowa, 52242
Suncoast Skin Solutions
Jacksonville, Florida, 32256
Kindred Hair and Skin Center
Marriottsville, Maryland, 21104
Raven Clinical Reseach
McLean, Virginia, 22102
University of Miami
Miami, Florida, 33136
Skin Research of South Florida LLC
Miami, Florida, 33173
Frontier Dermatology
Mill Creek, Washington, 98012
Twin Cities Dermatology Center
Minneapolis, Minnesota, 55416
University of Minnesota
Minneapolis, Minnesota, 55455
C2 Research Center
Montgomery, Alabama, 36117
Cura Clinical Research
Oxnard, California, 93030
UPMC
Pittsburgh, Pennsylvania, 15213
NW Dermatology Institute
Portland, Oregon, 97210
Stanford
Redwood City, California, 94063
Southern California Clinical Research
Santa Ana, California, 92701
Epiphany Dermatology
Southlake, Texas, 76092
Michigan Dermatology Institute
Waterford, Michigan, 48328
France10 sites
Ch Victor Dupouy
Argenteuil, 95100
University hospital of Bordeaux
Bordeaux, New Aquitaine, 33000
CHU de CAEN
Caen, 14033
Chu Dijon Bourgogne
Dijon, 21000
CHU de Grenoble Alpes
La Tronche, 38700
Hôpital Saint Vincent de Paul
Lille, 59000
Centre Sabouraud
Paris, Île-de-France Region, 75010
CHU de Rennes Hôpital Pontchaillou
Rennes, 35000
Rouen University Hospital
Rouen, 76000
Hôpital Larrey
Toulouse, 31059
Japan10 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Nagomi Dermatology Clinic
Ebina, Kanagawa, 243-0432
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Teikyo University Hospital
Itabashi-Ku, Tokyo, 173-8606
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, 807-8556
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Niigata University Medical & Dental Hospital
Niigata, Niigata, 951-8520
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-0051
Tohoku University Hospital
Sendai, Miyagi, 908-8574
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023
China8 sites
Beijing Tongren Hospital
Beijing, 100006
Peking University First Hospital
Beijing, 100034
Peking University People's Hospital
Beijing, 100044
The Fist Hospital of Jilin Province
Changchun, 130021
Xiangya Hospital, Central South University
Changsha, 410028
Dermatology Hospital of Southern Medical University
Guangzhou, 510091
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
Shanghai Skin Disease Hospital
Shanghai, 200443
United Kingdom8 sites
Royal United Hospital Bath
Bath, BA1 3NG
University Hospitals Sussex
Brighton, EAST Sussex, BN2 3EW
NHS Fife
Dunfermline, FIFE, KY120SU
NHS Greater Glasgow and Clyde
Glasgow, G4 0SF
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL13PX
Whipps Cross (Barts Health)
London, E11 1NR
London North West University Healthcare Trust
London, NW10 7NS
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
Italy6 sites
A.O.U.C Policlinico de Bari
Bari, BA, 70124
Irccs, Aoubo, Policlinico S.Orsola
Bologna, 40138
AO G. Rodolico - San Marco di Catania UOC DERMATOLOGIA
Catania, 95123
Policlinico Umberto I
Roma, 00161
Policlinico Tor Vergata
Rome, 00133
Istituto clinico Humanitas
Rozzano, Milan, 20089
About this study
Official title: PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are:
- Patchy alopecia (PA), as seen in 90% of clinical diagnoses
- Alopecia totalis (AT), that affects all scalp hair
- Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020).
Read more
Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally.
Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib.
The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.
- Conditions
- Alopecia Areata
- Being tested
- Ritlecitinib
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitlecitinibDrug
As provided in the real world practice.
| Study group | Role | What they receive |
|---|---|---|
| Alopecia Areata (AA) patients treated with ritlecitinib | Not described Receives: Drug: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24
SALT score is used to calculate the severity of alopecia areata. Physician calculate it by summing the percentage of hair loss in different regions of scalp.
Measured: 24 weeks from initiation of the treatment
Secondary outcomes (24)
Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status
Number/percentage of patients by age, sex, race, ethnicity, socio-economic status, area of residence, smoking status. Race and ethnicity variables will only be collected in participating countries where it is allowed.
Measured: Baseline
Demographic Characteristic of Participants: Date of Initial AA diagnosis
Measured: Baseline
Demographic Characteristics of participants: Duration of AA since diagnosis
Measured: Baseline
Demographic characteristics of participants: Duration of current AA Episode
Measured: Baseline
Demographic Characteristic of Participants: Predominant AA phenotype
Predominant AA phenotype (eg, patchy; ophiasis; AT; AU, etc
Measured: Baseline
Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score
SALT score is used to calculate the severity of alopecia areata.
Measured: Baseline
Clinical characteristics of participants: Eyelash Assessment (ELA) score
ELA score is used to calculate the severity of the involvement of eyelashes.
Measured: Baseline
Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score
EBA score is used to calculate the severity of the involvement of eyebrows
Measured: Baseline
Clinical Characteristics of participants: number of affected nails
Measured: Baseline
Clinical Characteristics of participants: Presence of Beard involvement
Determine whether the beard is affected or not.
Measured: Baseline
AA treatment history of participants: number of patients with prior AA treatments
Measured: Baseline
AA treatment history of participants: prior AA treatment class and route
Measured: Baseline
AA treatment history of participants: duration of prior therapy / frequency
Measured: baseline
AA treatment history of the participants: total number of prior AA treatments
Measured: Baseline
RW effectiveness of ritlecitinib: proportion of patients with <20 in SALT score
decrease in SALT score is the indicator of effectiveness.
Measured: week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: Proportion of patients with <10
Decrease in SALT score is the indicator of effectiveness
Measured: week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: Change from baseline in SALT score
Decrease in SALT score is the indicator of effectiveness
Measured: week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyebrow Assessment score (EBA)
Improvement in EBA score will indicate ritlecitinib effectiveness in eyebrow involvement.
Measured: Week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyelashes Assessment Score (ELA)
Improvement in ELA score will indicate ritlecitinib effectiveness in eyebrow involvement.
Measured: Week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: proportion of patients with improvement from abnormal baseline in beard assessment and nail involvement
Measured: week 24, 48, 72 and 96
Patient reported outcome: Evaluate ritlecitinib treatment satisfaction
Patient-reported satisfaction (P-sat) Response (defined as slightly, moderately, or very satisfied) at 24, 48, 72 and 96 weeks
Measured: week 24, 48, 72 and 96
Patient reported outcome: Evaluate impression of hair growth
Patient Global Impression of Change (PGI-C) Response (defined as a score of moderate to severe), at 24, 48, 72 and 96 weeks
Measured: week 24, 48, 72 and 96
Evaluate impact of ritlecitinib: Patient reported quality of life
Changes in AAPPO. · Improvement in hair loss AAPPO items 1-4, defined as a score of 0="no hair loss" or
1=" little hair loss", among patients with a baseline score 2-4 indicating moderate-complete hair loss.
Measured: week 24, 48, 72 and 96
Evaluate impact of ritlecitinib: Patient reported quality of life
Change from baseline in emotional symptoms (ES) and activity limitations (AL) subscores
Measured: week 24, 48, 72 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start7 Aug 2024
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531109
- Sponsor's protocol ID
- B7981105
- Other IDs
- NCT06531109
- Acronym
- PRESTO
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.