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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03989206




Registration number
NCT03989206
Ethics application status
Date submitted
14/06/2019
Date registered
18/06/2019

Titles & IDs
Public title
Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis
Scientific title
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
RD.06.SPR.118163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-Severe Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nemolizumab

Experimental: Nemolizumab - Nemolizumab administered via subcutaneous injection


Treatment: Drugs: Nemolizumab
Nemolizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of TEAEs
Timepoint [1] 0 0
Baseline to Week 200
Primary outcome [2] 0 0
Incidence of Serious TEAEs
Timepoint [2] 0 0
Baseline to Week 200
Primary outcome [3] 0 0
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Timepoint [3] 0 0
Baseline to Week 200
Secondary outcome [1] 0 0
Proportion of Participants with IGA score = 0-1 at Each Visit
Timepoint [1] 0 0
Baseline to Week 200
Secondary outcome [2] 0 0
Proportion of Participants with EASI-75 at Each Visit
Timepoint [2] 0 0
Baseline to Week 200
Secondary outcome [3] 0 0
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
Timepoint [3] 0 0
Baseline to Week 200
Secondary outcome [4] 0 0
Proportion of Participants with IGA = 2 at Each Visit
Timepoint [4] 0 0
Baseline to Week 200
Secondary outcome [5] 0 0
Change and Percent Change From Baseline in SCORAD Score at Each Visit
Timepoint [5] 0 0
Baseline to Week 200
Secondary outcome [6] 0 0
Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
Timepoint [6] 0 0
Baseline to Week 200
Secondary outcome [7] 0 0
Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
Timepoint [7] 0 0
Baseline to Week 200
Secondary outcome [8] 0 0
Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
Timepoint [8] 0 0
Baseline to Week 200
Secondary outcome [9] 0 0
Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
Timepoint [9] 0 0
Baseline to Week 200
Secondary outcome [10] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI)
Timepoint [10] 0 0
Baseline to Week 200
Secondary outcome [11] 0 0
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
Timepoint [11] 0 0
Baseline to Week 200
Secondary outcome [12] 0 0
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
Timepoint [12] 0 0
Baseline to Week 200
Secondary outcome [13] 0 0
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
Timepoint [13] 0 0
Baseline to Week 200
Secondary outcome [14] 0 0
Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200
Timepoint [14] 0 0
Baseline to Week 200
Secondary outcome [15] 0 0
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Timepoint [15] 0 0
Baseline to Week 200
Secondary outcome [16] 0 0
Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
Timepoint [16] 0 0
Baseline to Week 200
Secondary outcome [17] 0 0
Time to First Relapse
Timepoint [17] 0 0
Baseline to Week 200
Secondary outcome [18] 0 0
Duration of Remission
Timepoint [18] 0 0
Baseline to Week 200
Secondary outcome [19] 0 0
Time to Permanent Study Drug Discontinuation
Timepoint [19] 0 0
Baseline to Week 200

Eligibility
Key inclusion criteria
Key

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
3. Body weight < 30 kg
4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
6. Any clinically significant issue, based investigator judgement

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
1700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Galderma Investigational Site 5441 - Darlinghurst
Recruitment hospital [2] 0 0
Galderma Investigational Site 5759 - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational Site 6152 - Westmead
Recruitment hospital [4] 0 0
Galderma Investigational Site 5638 - Benowa
Recruitment hospital [5] 0 0
Galderma Investigational Site 6161 - Brisbane
Recruitment hospital [6] 0 0
Galderma Investigational Site 6159 - Woodville
Recruitment hospital [7] 0 0
Galderma Investigational Site 6131 - Carlton
Recruitment hospital [8] 0 0
Galderma Investigational Site 5366 - East Melbourne
Recruitment hospital [9] 0 0
Galderma Investigational Site 5458 - Parkville
Recruitment hospital [10] 0 0
Galderma Investigational Site 6160 - Parkville
Recruitment hospital [11] 0 0
Galderma Investigational Site 6153 - Victoria Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment postcode(s) [11] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
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Connecticut
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Florida
Country [7] 0 0
United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Kansas
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Kentucky
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Maine
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Michigan
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Missouri
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Montana
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Nebraska
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New Hampshire
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Washington
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Vienna
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Belgium
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Vlaams-Brabant
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Liège
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Bulgaria
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Pleven
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Sofia
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Stara Zagora
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Canada
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Ontario
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Tallinn
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Tartu
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Quimper
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Toulon
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Toulouse
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Valence
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Tbilisi
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Zugdidi
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Augsburg
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Bad Bentheim
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Bielefeld
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Bonn
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Dülmen
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Gera
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Goettigen
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Halle
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Hamburg
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Heidelberg
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Kiel
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Langenau
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Mainz
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Munich
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Osnabrück
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Stuttgart
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Tuebingen
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Hungary
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Budapest
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Hungary
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Debrecen
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Gyula
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Hungary
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Veszprem
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Italy
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Bologna
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Italy
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L'Aquila
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Italy
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Vicenza
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Korea, Republic of
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Bucheon-Si
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Incheon
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Seoul
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Latvia
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Liepaja
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Talsi
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Vilnius
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Rotterdam
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Hamilton
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New Zealand
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Wellington
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Bialystok
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Chorzów
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Czestochowa
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Gdansk
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Gdynia
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Lublin
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Nowa Sól
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Olsztyn
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Ostrowiec Swietokrzyski
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Poznan
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Rzeszów
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Szczecin
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Tarnow
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Warsaw
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Warszawa
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Wroclaw
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Poland
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Lódz
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Singapore
State/province [138] 0 0
Singapore
Country [139] 0 0
Spain
State/province [139] 0 0
Alicante
Country [140] 0 0
Spain
State/province [140] 0 0
Barcelona
Country [141] 0 0
Spain
State/province [141] 0 0
L'Hospitalet De Llobregat
Country [142] 0 0
Spain
State/province [142] 0 0
Las Palmas De Gran Canaria
Country [143] 0 0
Spain
State/province [143] 0 0
Madrid
Country [144] 0 0
Spain
State/province [144] 0 0
Pamplona
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Barnsley
Country [146] 0 0
United Kingdom
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Blackpool
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cannock
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Dudley
Country [149] 0 0
United Kingdom
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Glasgow
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Liverpool
Country [151] 0 0
United Kingdom
State/province [151] 0 0
London
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Manchester
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Newcastle
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Stockton-on-Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galderma R&D
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03989206