Clinical trial NCT05492578: Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
Official title: A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 1551
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.

The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline.

Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.


Eligibility criteria: Inclusion Criteria:

* Participant must be at least 12 years of age inclusive at the time of signing the informed consent.
* Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.

  * Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
  * Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:

    * The first group: participants at Week 24 in the DRI17336 study who have not achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) ≥ 2.
    * The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
    * The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
  * Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
* Complied with the previous clinical trial protocol to the satisfaction of the investigator
* Body weight must be ≥25 kg
* Provided signed informed assent/or consent and able to comply with the requirements of the protocol Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Developed a medical condition that would preclude participation as described in the section for permanent discontinuation of the feeder study or LTS17367 protocol
* Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
* History of solid organ or stem cell transplant
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
* Participants positive for human immunodeficiency virus (HIV); participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA PCR test
* History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
* Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening
* Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:

  1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
  2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
  3. For whom review and approval from Sponsor have been granted are eligible
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
* Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
* Any medical condition which, in the opinion of the Investigator may present an unreasonable risk to the study participant as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments
* In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of participants who experienced treatment-emergent adverse event (TEAE)
timeFrame: Baseline to Week 332
Secondary outcomes:
measure: Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)
timeFrame: Baseline to Week 332
measure: Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)
timeFrame: Baseline to Week 332
measure: Percentage of participants who experienced TEAE leading to treatment discontinuation
timeFrame: Baseline to Week 332
measure: Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
timeFrame: DRI17366 Baseline to Week 332
measure: Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
timeFrame: DRI17366 Baseline to Week 332
measure: Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24
timeFrame: DRI17366 Baseline to Week 332
measure: Proportion of participants with a response of Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24
timeFrame: Baseline to Week 332
measure: Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Proportion of participants with vIGA-AD score 0 [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit
timeFrame: Baseline to Week 332
measure: Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment
timeFrame: Baseline to Week 332
measure: Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment
timeFrame: Baseline to Week 332
measure: Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study
timeFrame: Baseline to Week 332
measure: Number of days on topical medication (per patient-year) in all participants entering the study
timeFrame: Baseline to Week 332
measure: Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Change from feeder study baseline in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Change from feeder study baseline in body surface area affected by AD (BSA-AD) [each LTS17367 visit]
timeFrame: Baseline to Week 332
measure: Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)
timeFrame: Baseline to Week 332
measure: Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)
timeFrame: Baseline to Week 332
measure: Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)
timeFrame: Baseline to Week 332
measure: Serum amlitelimab concentration assessed at prespecified time points through the end of the study
timeFrame: Baseline to Week 332
measure: Number of participants with anti-drug antibodies (ADAs) of amlitelimab at specified timepoints
timeFrame: Baseline to Week 332
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama - Homewood- Site Number : 8401101
state: Alabama
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery- Site Number : 8401119
state: Arizona
city: Anaheim
country: United States
facility: Orange County Clinical Trials- Site Number : 8401271
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology- Site Number : 8401025
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research- Site Number : 8401022
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials- Site Number : 8401099
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research- Site Number : 8401027
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials- Site Number : 8401188
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute- Site Number : 8401028
state: California
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach- Site Number : 8401030
state: Florida
city: Doral
country: United States
facility: Revival Research - Doral- Site Number : 8401012
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research- Site Number : 8401094
state: Florida
city: Kendall
country: United States
facility: C&R Research Services - Kendall- Site Number : 8401029
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami II- Site Number : 8401019
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates- Site Number : 8401088
state: Florida
city: Miami
country: United States
facility: Future Care Solution - Miami- Site Number : 8401144
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research- Site Number : 8401095
state: Florida
city: Miami
country: United States
facility: Florida International Research Center- Site Number : 8401091
state: Florida
city: Orlando
country: United States
facility: K2 South Orlando - South Orange Avenue- Site Number : 8401268
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals (GCP)- Site Number : 8401045
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida- Site Number : 8401023
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa- Site Number : 8401013
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Laboratory- Site Number : 8401004
state: Georgia
city: Chicago
country: United States
facility: Northwestern University- Site Number : 8401038
state: Illinois
city: Louisville
country: United States
facility: Skin Sciences- Site Number : 8401039
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072
state: Louisiana
city: Gretna
country: United States
facility: BRCR Global Gretna- Site Number : 8401243
state: Louisiana
city: Baltimore
country: United States
facility: Continental Clinical Research Solutions- Site Number : 8401011
state: Maryland
city: Missoula
country: United States
facility: Boeson Research- Site Number : 8401269
state: Montana
city: Henderson
country: United States
facility: Pulmonology Group - Henderson- Site Number : 8401169
state: Nevada
city: Rochester
country: United States
facility: Skin Search Rochester- Site Number : 8401216
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8401005
state: Oklahoma
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8401031
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts - Site Number : 8401059
state: South Dakota
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee- Site Number : 8401008
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center- Site Number : 8401248
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates- Site Number : 8401093
state: Texas
city: Dallas
country: United States
facility: Reveal Research Institute - Dallas- Site Number : 8401219
state: Texas
city: Southlake
country: United States
facility: Stryde Research - Epiphany Dermatology- Site Number : 8401185
state: Texas
city: Norfolk
country: United States
facility: Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
state: Virginia
city: Cheyenne
country: United States
facility: Cheyenne Urological Pc / Wyoming Research Foundation Inc- Site Number : 8401234
state: Wyoming
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320011
city: Córdoba
country: Argentina
facility: Investigational Site Number : 0320014
city: Carlton
country: Australia
facility: Investigational Site Number : 0363002
state: Victoria
city: Melbourne
country: Australia
facility: Investigational Site Number : 0363003
state: Victoria
city: Parkville
country: Australia
facility: Investigational Site Number : 0363001
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
state: Bahia
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
state: Rio Grande Do Sul
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC- Site Number : 0760001
state: São Paulo
city: São Paulo
country: Brazil
facility: Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1002004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002005
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002003
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002006
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002002
city: Calgary
country: Canada
facility: Investigational Site Number : 1240019
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site Number : 1240023
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240016
state: Alberta
city: Barrie
country: Canada
facility: Investigational Site Number : 1240014
state: Ontario
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240020
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240017
state: Ontario
city: Markham
country: Canada
facility: Investigational Site Number : 1241106
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Niagara Falls
country: Canada
facility: Investigational Site Number : 1241108
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240024
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240021
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240026
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1241107
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1241101
state: Ontario
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Guangzhou
country: China
facility: Investigational Site Number : 1560036
city: Ningbo
country: China
facility: Investigational Site Number : 1560035
city: Wuhan
country: China
facility: Investigational Site Number : 1560038
city: Brno
country: Czechia
facility: Investigational Site Number : 2032108
city: Kutná Hora
country: Czechia
facility: Investigational Site Number : 2032106
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Prague
country: Czechia
facility: Investigational Site Number : 2032102
city: Prague
country: Czechia
facility: Investigational Site Number : 2032101
city: Prague
country: Czechia
facility: Investigational Site Number : 2032103
city: Lille
country: France
facility: Investigational Site Number : 2500001
city: Berlin
country: Germany
facility: Investigational Site Number : 2762203
city: Blankenfelde-mahlow
country: Germany
facility: Investigational Site Number : 2762202
city: Gera
country: Germany
facility: Investigational Site Number : 2762207
city: Kiel
country: Germany
facility: Investigational Site Number : 2762208
city: Lübeck
country: Germany
facility: Investigational Site Number : 2761002
city: Münster
country: Germany
facility: Investigational Site Number : 2762201
city: Debrecen
country: Hungary
facility: Investigational Site Number : 3482303
city: Szolnok
country: Hungary
facility: Investigational Site Number : 3482306
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760008
city: Torino
country: Italy
facility: Investigational Site Number : 3800020
city: Obihiro
country: Japan
facility: Investigational Site Number : 3923114
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3923101
state: Hokkaido
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number : 3923113
state: Kanagawa
city: Sakai
country: Japan
facility: Investigational Site Number : 3923110
state: Osaka
city: Mibu
country: Japan
facility: Investigational Site Number : 3923106
state: Tochigi
city: Chuo
country: Japan
facility: Investigational Site Number : 3923115
state: Tokyo
city: Edogawa
country: Japan
facility: Investigational Site Number : 3923104
state: Tokyo
city: Minato
country: Japan
facility: Investigational Site Number : 3923107
state: Tokyo
city: Setagaya
country: Japan
facility: Investigational Site Number : 3923105
state: Tokyo
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920001
state: Tokyo
city: Habikino
country: Japan
facility: Investigational Site Number : 3923109
city: Hiroshima
country: Japan
facility: Investigational Site Number : 3920007
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3923108
city: Kyoto
country: Japan
facility: Investigational Site Number : 3923102
city: Tokyo
country: Japan
facility: Investigational Site Number : 3923112
city: Yokohama
country: Japan
facility: Investigational Site Number : 3923113
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Bupyeong-gu
country: Korea, Republic of
facility: Investigational Site Number : 4100015
state: Incheon-gwangyeoksi
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6162414
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6162418
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6162417
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6162415
state: Lódzkie
city: Lodz
country: Poland
facility: Investigational Site Number : 6162416
state: Lódzkie
city: Krakow
country: Poland
facility: Investigational Site Number : 6162407
state: Malopolskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6162406
state: Malopolskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6162412
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6162411
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6162413
state: Mazowieckie
city: Rzeszow
country: Poland
facility: Investigational Site Number : 6162401
state: Podkarpackie
city: Bialystok
country: Poland
facility: Investigational Site Number : 6162419
state: Podlaskie
city: Gdansk
country: Poland
facility: Investigational Site Number : 6162402
state: Pomorskie
city: Gdansk
country: Poland
facility: Investigational Site Number : 6162403
state: Pomorskie
city: Gdynia
country: Poland
facility: Investigational Site Number : 6162404
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6162405
state: Slaskie
city: Szczecin
country: Poland
facility: Investigational Site Number : 6162410
state: Zachodniopomorskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6162409
city: Krakow
country: Poland
facility: Investigational Site Number : 6162408
city: Pontevedra
country: Spain
facility: Investigational Site Number : 7242504
state: Galicia [Galicia]
city: Madrid
country: Spain
facility: Investigational Site Number : 7242503
state: Madrid, Comunidad De
city: Alicante
country: Spain
facility: Investigational Site Number : 7242505
city: Córdoba
country: Spain
facility: Investigational Site Number : 7242501
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1583201
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1583202
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taoyuan City
country: Taiwan
facility: Investigational Site Number : 1583203
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840001
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Hampshire
city: London
country: United Kingdom
facility: Investigational Site Number : 8262603
state: London, City Of
city: London
country: United Kingdom
facility: Investigational Site Number : 8262601
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Investigational Site Number : 8260010
state: Nottinghamshire
city: Bristol
country: United Kingdom
facility: Investigational Site Number : 8260013
city: Liverpool
country: United Kingdom
facility: Investigational Site Number : 8260008
Study officials:
References: