ALLEGRO-LT: Long-Term PF-06651600 for the Treatment of Alopecia Areata

Sponsor

Pfizer (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04006457

Collaborator

(none)

1,050

Enrollment

149

Locations

Arms

78.5

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a global Phase 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 alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: PF-06651600 Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1050 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

Actual Study Start Date :

Jul 18, 2019

Anticipated Primary Completion Date :

Jul 8, 2024

Anticipated Study Completion Date :

Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment sequence 1 Participants 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.	Drug: PF-06651600 50 mg oral tablets/capsules Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine Single intramuscular injection administered to patients participating in the vaccine sub-study Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine Single intramuscular injection administered to patients participating in the vaccine sub-study
Experimental: Treatment sequence 2 Participants 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.	Drug: PF-06651600 50 mg oral tablets/capsules Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine Single intramuscular injection administered to patients participating in the vaccine sub-study Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine Single intramuscular injection administered to patients participating in the vaccine sub-study

Arm

Intervention/Treatment

Experimental: Treatment sequence 1

Participants 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.

Drug: PF-06651600

50 mg oral tablets/capsules

Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

Experimental: Treatment sequence 2

Participants 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.

Drug: PF-06651600

50 mg oral tablets/capsules

Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine

Single intramuscular injection administered to patients participating in the vaccine sub-study

Outcome Measures

Primary Outcome Measures

Number of subjects reporting treatment-emergent adverse events [Baseline through Month 36]
Number of subjects reporting serious adverse events [Baseline through Month 36]
Number of subjects reporting adverse events leading to discontinuation [Baseline through Month 36]
Number of subjects with clinically significant abnormalities in vital signs [Baseline through Month 36]
Number of subjects with clinically significant abnormalities in clinical laboratory values [Baseline through Month 36]
Vaccine sub-study: Percentage of subjects with a tetanus booster response [Vaccine sub-study Month 1]
Tetanus booster response is defined as 1) ≥4 fold rise in anti-tetanus toxoid IgG antibody concentration at Day 30 if the pre-vaccination concentration was ≤2.7 IU/mL; 2) ≥2 fold rise in anti tetanus toxoid IgG antibody if the pre-vaccination concentration was >2.7 IU/mL

Secondary Outcome Measures

Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10 [Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36]
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20 [Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36]
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Change from baseline in SALT score [Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36]
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with a 75% improvement in SALT score from baseline [Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36]
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score [Months 1, 3, 6, 12, 18, 24, and 36]
EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score [Months 1, 3, 6, 12, 18, 24, and 36]
ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved" [Months 1, 3, 6, 9, 12, 18, 24, and 36]
PGI-C is a self administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has: …", with 7 responses ranging from "greatly improved" to "greatly worsened."
Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains [Months 1, 3, 6, 9, 12, 18, 24, and 36]
The 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 subscale score of the Hospital Anxiety and Depression Scale (HADS) [Months 1, 3, 6, 9, 12, 18, 24, and 36]
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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 subscale score of the Hospital Anxiety and Depression Scale (HADS) [Months 1, 3, 6, 9, 12, 18, 24, and 36]
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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.
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 [Months 1, 3, 6, 9, 12, 18, 24, and 36]
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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.
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 [Months 1, 3, 6, 9, 12, 18, 24, and 36]
HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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.
Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response [Vaccine sub-study Month 1]
Meningococcal serogroup C response is defined as achieving ≥1:8 human serum bactericidal activity (hSBA) (in participants with undetectable pre-vaccination assay titers)
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL [Vaccine sub-study Month 1]
Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL [Vaccine sub-study Month 1]
Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline [Vaccine sub-study Month 1]
Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values [Vaccine sub-study Month 1]
Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels [Vaccine sub-study Month 1]
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 Month 1]
Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C [Vaccine sub-study Day 1 and Month 1]
Number of subjects reporting treatment-emergent adverse events [Month 37 through Month 60]
Number of subjects reporting serious adverse events [Month 37 through Month 60]
Number of subjects reporting adverse events leading to discontinuation [Month 37 through Month 60]
Number of subjects with clinically significant abnormalities in vital signs [Month 37 through Month 60]
Number of subjects with clinically significant abnormalities in clinical laboratory values [Month 37 through Month 60]
Vaccine sub-study: Number of subjects reporting serious adverse events [Vaccine sub-study Month 1]
Vaccine sub-study: Number of subjects reporting adverse events [Vaccine sub-study Month 1]
Vaccine sub-study: Number of subjects reporting adverse events leading to discontinuation [Vaccine sub-study Month 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

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
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)

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham Hosptial Outreach Lab	Birmingham	Alabama	United States	35233
2	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
3	The University of Alabama at Birmingham, Department of Dermatology	Birmingham	Alabama	United States	35294
4	Mosaic Dermatology	Beverly Hills	California	United States	90211
5	Univ of California, Irvine, Dermatology Clinical Research Center	Irvine	California	United States	92697
6	Dermatology Specialists Inc.	Murrieta	California	United States	92562
7	University of California, San Francisco	San Francisco	California	United States	94115
8	Kaiser Permanente Clinical Trials Unit	San Francisco	California	United States	94118
9	Southern California Dermatology, Inc.	Santa Ana	California	United States	92701
10	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
11	University of Colorado Hospital Clinical and Translational Research Center	Aurora	Colorado	United States	80045
12	University of Colorado Hospital Outpatient Pavilion	Aurora	Colorado	United States	80045
13	Yale School of Medicine	New Haven	Connecticut	United States	06510
14	Investigational Drug Services	New Haven	Connecticut	United States	06511
15	Medstar Georgetown University Hospital - Department of Otolaryngology	Washington	District of Columbia	United States	20007
16	Medstar Georgetown University Hospital-Dept of Otolaryngology	Washington	District of Columbia	United States	20007
17	Medstar Washington Hospital Center-Claude Nogay Research Pharmacy	Washington	District of Columbia	United States	20010
18	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
19	Medstar Georgetown University Hospital - Department of Pediatrics	Washington	District of Columbia	United States	20016
20	Siperstein Dermatology Group	Boynton Beach	Florida	United States	33472
21	Park Avenue Dermatology	Orange Park	Florida	United States	32073
22	ForCare Clinical Research	Tampa	Florida	United States	33613
23	Velocity Clinical Research - Boise	Meridian	Idaho	United States	83642
24	Northwestern Medical Group	Chicago	Illinois	United States	60611
25	Northwestern Medicine Diagnostic Testing Center	Chicago	Illinois	United States	60611
26	Northwestern Medicine	Chicago	Illinois	United States	60611
27	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
28	Summit Dermatology and Aesthetic Surgery (in c/o TrialSpark, Inc)	Oakbrook Terrace	Illinois	United States	60181
29	NorthShore University HealthSystem Dermatology Clinical Trials Unit	Skokie	Illinois	United States	60077
30	Northshore University HealthSystem/Dermatology	Skokie	Illinois	United States	60077
31	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
32	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46250
33	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
34	Medstar Georgetown University Hospital - Department of Dermatology	Chevy Chase	Maryland	United States	20815
35	Massachusetts General Hospital - Clinical Unit for Research Trials in Skin (CURTIS)	Boston	Massachusetts	United States	02114
36	University of Minnesota Clinical Research Unit (CRU)	Minneapolis	Minnesota	United States	55455
37	University of Minnesota Lillehei Clinical Research Unit (LCRU)	Minneapolis	Minnesota	United States	55455
38	Skin Specialists PC	Omaha	Nebraska	United States	68144
39	Schweiger Dermatology Group	Verona	New Jersey	United States	07044
40	NYU School of Medicine, The Ronald O. Perelman Department of Dermatology	New York	New York	United States	10016
41	Pura Dermatology (in c/o TrialSpark, Inc)	New York	New York	United States	10018
42	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
43	UNC CTRC	Chapel Hill	North Carolina	United States	27514
44	UNC Hospitals, Investigational Drug Service	Chapel Hill	North Carolina	United States	27514
45	UNC Dermatology Clinical Trials Unit	Chapel Hill	North Carolina	United States	27516
46	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
47	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma	United States	74136
48	Oregon Medical Research Center	Portland	Oregon	United States	97223
49	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
50	Tamjidi Skin Institute (in c/o TrialSpark, Inc)	Vienna	Virginia	United States	22182
51	CINME Centro de Investigaciones Metabolicas	Caba	Buenos Aires	Argentina	C1027AAP
52	Psoriahue Medicina Interdisciplinaria	Caba		Argentina	C1425DKG
53	Premier Specialists Pty Ltd	Kogarah	New South Wales	Australia	2217
54	St George Dermatology & Skin Cancer Centre	Kogarah	New South Wales	Australia	2217
55	The Skin Centre	Benowa	Queensland	Australia	4217
56	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland	Australia	4102
57	Skin Health Institute	Carlton	Victoria	Australia	3053
58	Sinclair Dermatology	East Melbourne	Victoria	Australia	3002
59	Royal Melbourne Hospital, Melbourne Health	Parkville	Victoria	Australia	3050
60	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
61	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
62	Eastern Canada Cutaneous Research Associates Ltd.	Halifax	Nova Scotia	Canada	B3H 1Z2
63	Guenther Research Inc	London	Ontario	Canada	N6A 3H7
64	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X2
65	The Centre for Clinical Trials	Oakville	Ontario	Canada	L6J 7W5
66	SKiN Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
67	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario	Canada	L4C 9M7
68	Medicor Research Inc	Sudbury	Ontario	Canada	P3A 1W8
69	Sudbury Skin Clinique	Sudbury	Ontario	Canada	P3C 1X8
70	Research Toronto	Toronto	Ontario	Canada	M4W 2N2
71	Innovaderm Research Inc.	Montreal	Quebec	Canada	H2X 2V1
72	Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)	Quebec		Canada	G1V 4X7
73	Centro Medico Skin Med	Santiago	LAS Condes	Chile	7580206
74	Centro Internacional de Estudios Clinicos - CIEC	Santiago	Recoleta	Chile	8420383
75	Medical Skin Center	Vina del Mar	Valparaiso	Chile	2530900
76	Clinica Dermacross S.A.	Santiago	Vitacura	Chile	7640881
77	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing	China	100050
78	Peking University Third Hospital	Beijing	Beijing	China	100191
79	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080
80	The University of Hong Kong - Shenzhen Hospital	Shenzhen	Guangdong	China	518053
81	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
82	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China	210029
83	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200025
84	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003
85	Fundacion Centro de Investigacion Clinica CIC	Medellin	Antioquia	Colombia	050001
86	Fundacion Hospitalaria San Vicente de Paul	Medellin	Antioquia	Colombia	050010
87	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S	Bogota D.C.		Colombia	110221
88	DERMAMEDICA s.r.o.	Nachod		Czechia	547 01
89	Fakultni nemocnice Olomouc	Olomouc		Czechia	779 00
90	Clintrial s.r.o.	Praha 10		Czechia	100 00
91	Sanatorium profesora Arenbergera	Praha 1		Czechia	110 00
92	Fachklinik Bad Bentheim	Bad Bentheim		Germany	48455
93	Emovis GmbH	Berlin		Germany	10629
94	Universitaetsklinikum Erlangen	Erlangen		Germany	91054
95	University Hospital Frankfurt	Frankfurt am Main		Germany	60590
96	University Hospital Schleswig-Holstein	Luebeck		Germany	23538
97	University Hospital Muenster	Muenster		Germany	48149
98	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
99	Tohoku University Hospital	Sendai	Miyagi	Japan	980-8574
100	Hamamatsu University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
101	Juntendo Tokyo Koto Geriatric Medical Center	Koto-ku	Tokyo	Japan	136-0075
102	Kyorin University Hospital	Mitaka-shi	Tokyo	Japan	181-8611
103	Osaka Metropolitan University Hospital	Osaka		Japan	545-8586
104	Tokyo Medical University Hospital	Tokyo		Japan	160-0023
105	Pusan National University Hospital	Busan		Korea, Republic of	49241
106	Seoul National University Hospital	Seoul		Korea, Republic of	03080
107	Sociedad de Metabolismo y Corazon S.C.	Veracruz		Mexico	91900
108	Hospital D Maria	Veracruz		Mexico	91910
109	McBk S.C.	Grodzisk Mazowiecki		Poland	05-825
110	Centermed Krakow Sp.z o.o.	Krakow		Poland	31-530
111	Dermoklinika Centrum Medyczne s.c. M.Kierstan, J. Narbutt, A. Lesiak	Lodz		Poland	90-436
112	Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski		Poland	27-400
113	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin		Poland	71-434
114	RCMed Oddzial Warszawa	Warszawa		Poland	00-892
115	Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej	Warszawa		Poland	02-661
116	ETG Warszawa	Warszawa		Poland	02-793
117	Royalderm Agnieszka Nawrocka	Warszawa		Poland	02-962
118	EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej we Wroclawiu	Wroclaw		Poland	50-220
119	Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska	Wroclaw		Poland	50-566
120	Centrum Medyczne OPOROW	Wroclaw		Poland	52-416
121	State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Dermatovenerologic Dispensary"	Chelyabinsk		Russian Federation	454092
122	University Clinic of Kirov SMU	Kirov		Russian Federation	610035
123	Clinical Medical Center of Moscow State University of Medicine and Dentistry	Moscow		Russian Federation	111398
124	Federal State Autonomous Institution "National Medical Research Centre of Children's' Health"	Moscow		Russian Federation	119991
125	State Budgetary Institution of the Rostov Region "Dermatovenerologic Dispensary"	Rostov-on-Don		Russian Federation	344002
126	Limited Liability Company "Pierre Volkenshtein Skin Diseases Clinic"	Saint Petersburg,		Russian Federation	191123
127	Limited Liability Company "Centre Vitiligo" ("Centre Vitiligo" LLC)	Saint Petersburg		Russian Federation	191123
128	Saint Petersburg State Budgetary Healthcare Institution "Dermatovenerologic Dispensary No. 10 -	Saint Petersburg		Russian Federation	194021
129	State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Emergency Hospital	Yaroslavl		Russian Federation	150003
130	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
131	Hospital del Mar	Barcelona		Spain	08003
132	Hospital Universitario Reina Sofia	Cordoba		Spain	14004
133	Hospital Universitario Infanta Leonor	Madrid		Spain	28031
134	Hospital Universitario La Paz: Servicio de Farmacia	Madrid		Spain	28046
135	Hospital Universitario La Paz	Madrid		Spain	28046
136	Hospital Universitario y Politecnico La Fe	Valencia		Spain	46026
137	Chung-Shan Medical University Hospital	Taichung	R.o.c.	Taiwan	40201
138	Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City		Taiwan	83301
139	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
140	Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare	New Taipei City		Taiwan	23561
141	National Taiwan University Hospital	Taipei		Taiwan	100
142	Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital	Taoyuan City		Taiwan	333
143	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire	United Kingdom	SO14 0YG
144	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire	United Kingdom	SO16 6YD
145	University Hospitals Sussex NHS Foundation Trust (UHSussex)	Brighton		United Kingdom	BN2 1ES
146	NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital	Glasgow		United Kingdom	G51 4TF
147	Guy's and St Thomas Hospitals NHS Foundation Trust, St Thomas Hospital	London		United Kingdom	SE1 7EH
148	Guy's and St Thomas' Hospitals NHS Foundation Trust, St Thomas' Hospital	London		United Kingdom	SE1 7EH
149	Guy's and St Thomas' Hospitals NHS Foundation Trust, Guy's Hospital	London		United Kingdom	SE1 9RT