AzTrials
AzTrials

Dermatitis AtopicPEDISTADNCT03687359

Observational Evaluation of Atopic Dermatitis in Pediatric Patients

An observational study of Dermatitis Atopic, run by Sanofi at 182 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Primary Objectives: To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. To evaluate the time-course of AD and selected atopic comorbidities. Read more about this study

Who is it for?
Ages 0 to 11 years
Conditions the study is for
Dermatitis Atopic
How many people
1,860 participants
Where
182 sitesin 20 countries
Study dates
15 Aug 2019to 23 Jul 2035
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 0 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.

Who may be able to join

  • Patients with moderate to severe AD, according to the Investigator's assessment;
  • Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment.

Who cannot join

  • Concurrent participation in an interventional clinical trial which modifies patient care.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

182 sites in 20 countries.

182 sites in 20 countries

United States46 sites

  • Amarillo Center for Clinical Research- Site Number : 8400055

    Amarillo, Texas, 79124

  • Orange County Research Institute- Site Number : 8400028

    Anaheim, California, 92801

  • C Squared Research Center- Site Number : 8400068

    Birmingham, Alabama, 35209

  • Cahaba Dermatology & Skin Health Center- Site Number : 8400046

    Birmingham, Alabama, 35244

  • Daxia Trials- Site Number : 8400082

    Boca Raton, Florida, 33431

  • Frieder Dermatology- Site Number : 8400085

    Boca Raton, Florida, 33487

  • UNC Hospitals- Site Number : 8400016

    Chapel Hill, North Carolina, 27514

  • MUSC- Site Number : 8400013

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School of Medicine- Site Number : 8400001

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400017

    Cincinnati, Ohio, 45229

  • Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056

    Columbus, Georgia, 31904

  • Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072

    Coral Gables, Florida, 33146

  • Green Dermatology and Cosmetic Center. Site Number : 8400078

    Deerfield Beach, Florida, 33441

  • 2G Clinical Research Services- Site Number : 8400031

    Durham, North Carolina, 27713

  • Clinical Research Of Gastonia- Site Number : 8400041

    Gastonia, North Carolina, 28054

  • ADAC Research- Site Number : 8400048

    Greenville, South Carolina, 29607

  • Amedica Research Institute, Inc.- Site Number : 8400067

    Hialeah, Florida, 33013

  • Eastern Research, Inc.- Site Number : 8400032

    Hialeah, Florida, 33013

  • Heights Dermatology & Aesthetic Center- Site Number : 8400065

    Houston, Texas, 77008

  • Tokunbo T. Dada, MD PA- Site Number : 8400079

    Irvington, New Jersey, 07111

  • Michael W. Simon, M.D., PSC- Site Number : 8400073

    Lexington, Kentucky, 40517

  • Axis Clinical Trials- Site Number : 8400025

    Los Angeles, California, 90036

  • Madera Family Medical Group- Site Number : 8400054

    Madera, California, 93637

  • Dermatology Associates of Mid-Ohio- Site Number : 8400052

    Marion, Ohio, 43302

  • The Dermatology Institute of South Texas- Site Number : 8400076

    McAllen, Texas, 78501

  • Premier Dermatology Partners- Site Number : 8400075

    Miami, Florida, 33137

  • Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074

    Miami, Florida, 33155

  • Vista Health Research, LLC- Site Number : 8400034

    Miami, Florida, 33176

  • Medical College Of Wisconsin- Site Number : 8400008

    Milwaukee, Wisconsin, 53226

  • C2 Research Center, LLC- Site Number : 8400071

    Montgomery, Alabama, 36117

  • Park Plaza Dermatology- Site Number : 8400080

    New York, New York, 10019

  • Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077

    Newark, New Jersey, 07104

  • Providence Medical Center- Site Number : 8400081

    North Plainfield, New Jersey, 07060

  • Pediatric & Adult Research Center- Site Number : 8400040

    Orlando, Florida, 32825

  • Elias Dermatology LLC- Site Number : 8400086

    Pembroke Pines, Florida, 33024

  • Elias Dermatology LLC- Site Number : 8400087

    Pembroke Pines, Florida, 33024

  • Phoenix Children's Hospital, Inc.- Site Number : 8400015

    Phoenix, Arizona, 85016

  • The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007

    Plainfield, Indiana, 46168

  • The Indiana Clinical Trials Center, PC Site Number : 8400007

    Plainfield, Indiana, 46168

  • Dermatology Associates PC- Site Number : 8400049

    Rockville, Maryland, 20850

  • NorthShore University HealthSystem - Skokie- Site Number : 8400064

    Skokie, Illinois, 60077

  • Philip Fried, M.D., PLLC- Site Number : 8400029

    The Bronx, New York, 10463

  • Tiga Pediatrics, PC- Site Number : 8400037

    The Bronx, New York, 10463

  • VAMA Medical Health Center- Site Number : 8400083

    Union, New Jersey, 07083-5714

  • Carey Chronis, MD, FAAP- Site Number : 8400033

    Ventura, California, 93003

  • Michigan Dermatology Institute Site Number : 8400059

    Waterford, Michigan, 48328

Other trials in United States

Japan18 sites

  • Investigational Site Number : 3920011

    Fuchū, Tokyo, 183-8561

  • Investigational Site Number : 3920018

    Fukuoka, 813-0017

  • Investigational Site Number : 3920017

    Fukuyama-shi, 721-8511

  • Investigational Site Number : 3920003

    Habikino, Osaka, 583-8588

  • Investigational Site Number : 3920002

    Hiroshima, 734-8551

  • Investigational Site Number : 3920015

    Kumagaya-shi, 360-0018

  • Investigational Site Number : 3920004

    Kyoto, 602-8566

  • Investigational Site Number : 3920012

    Nagasaki, 852-8501

  • Investigational Site Number : 3920020

    Nagoya, 460-0001

  • Investigational Site Number : 3920008

    Obu-shi, 474-8710

  • Investigational Site Number : 3920005

    Osakasayama-shi, 589-8511

  • Investigational Site Number : 3920009

    Sagamihara, Kanagawa, 252-0315

  • Investigational Site Number : 3920014

    Sendai, 983-8512

  • Investigational Site Number : 3920019

    Sendai, 989-3126

  • Investigational Site Number : 3920001

    Tokyo, 157-8535

  • Investigational Site Number : 3920010

    Tsu, Mie-ken, 514-0125

  • Investigational Site Number : 3920016

    Yokohama, Kanagawa, 221-0825

  • Investigational Site Number : 3920016

    Yokohama, 221-0825

Other trials in Japan

Italy15 sites

  • Investigational Site Number : 3800012

    Bari, 70124

  • Investigational Site Number : 3800003

    Bologna, 40138

  • Investigational Site Number : 3800014

    Brescia, 25123

  • Investigational Site Number : 3800010

    Catania, 95123

  • Investigational Site Number : 3800001

    Milan, 20122

  • Investigational Site Number : 3800008

    Naples, Napoli, 80131

  • Investigational Site Number : 3800005

    Naples, 80131

  • Investigational Site Number : 3800011

    Padua, Padova, 35128

  • Investigational Site Number : 3800006

    Padua, Veneto, 35128

  • Investigational Site Number : 3800015

    Pavia, 27100

  • Investigational Site Number : 3800009

    Perugia, 06129

  • Investigational Site Number : 3800013

    Reggio Emilia, 42100

  • Investigational Site Number : 3800018

    Roma, 00137

  • Investigational Site Number : 3800004

    Terracina, Latina, 04019

  • Investigational Site Number : 3800007

    Trieste, 34137

Other trials in Italy

Argentina12 sites

  • Investigational Site Number : 0320009

    Bahía Blanca, Buenos Aires, 8000

  • Investigational Site Number : 0320006

    Buenos Aires, 1056

  • Investigational Site Number : 0320001

    Buenos Aires, 1121

  • Investigational Site Number : 0320002

    Buenos Aires, 1181

  • Investigational Site Number : 0320008

    Buenos Aires, 1181

  • Investigational Site Number : 0320005

    Ciudad Autonoma Buenos Aires, C1270AAN

  • Investigational Site Number : 0320003

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BEA

  • Investigational Site Number : 0320010

    Córdoba, 5000

  • Investigational Site Number : 0320004

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320013

    Salta, A4400

  • Investigational Site Number : 0320007

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigational Site Number : 0320007

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

China9 sites

  • Investigational Site Number : 1560004

    Beijing, 100045

  • Investigational Site Number : 1560006

    Changsha, 410007

  • Investigational Site Number : 1560001

    Chongqing, 400014

  • Investigational Site Number : 1560012

    Guangzhou, 510018

  • Investigational Site Number : 1560007

    Harbin, 150010

  • Investigational Site Number : 1560005

    Shanghai, 201102

  • Investigational Site Number : 1560011

    Shenzhen, 518020

  • Investigational Site Number : 1560002

    Suzhou, 215025

  • Investigational Site Number : 1560008

    Xuzhou, 221002

Other trials in China

Brazil8 sites

  • Universidade Federal do Paraná- Site Number : 0760003

    Curitiba, Paraná, 80060-000

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760004

    Curitiba, Paraná, 80060-900

  • Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760005

    Curitiba, Paraná, 80060-900

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90020-090

  • IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760009

    Rio de Janeiro, 22470-220

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto- Site Number : 0760007

    Sao Jose Rio Preto, 15090-000

  • Hospital Sao Paulo- Site Number : 0760006

    São Paulo, 04037-002

  • Clinica de Alergia Martti Antila- Site Number : 0760001

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Canada8 sites

  • Investigational Site Number : 1240004

    Calgary, Alberta, T3A 2N1

  • Investigational Site Number : 1240007

    Calgary, Alberta, T3B 6A8

  • Investigational Site Number : 1240010

    Halifax, Nova Scotia, B3K 5R3

  • Investigational Site Number : 1240001

    Markham, Ontario, L3P 1X2

  • Investigational Site Number : 1240006

    Montreal, Quebec, H3T 1C5

  • Investigational Site Number : 1240009

    Regina, Saskatchewan, S4V 1R9

  • Investigational Site Number : 1240008

    Toronto, Ontario, M5G 1X8

  • Investigational Site Number : 1240005

    Winnipeg, Manitoba, R3C ON2

Other trials in Canada

France8 sites

  • Investigational Site Number : 2500008

    Argenteuil, 95107

  • Investigational Site Number : 2500001

    Bordeaux, 33800

  • Investigational Site Number : 2500010

    Lille, 59020

  • Investigational Site Number : 2500006

    Marseille, 13385

  • Investigational Site Number : 2500005

    Martigues, 13500

  • Investigational Site Number : 2500002

    Nantes, 44093

  • Investigational Site Number : 2500003

    Paris, 75015

  • Investigational Site Number : 2500011

    Toulouse, 31059

Other trials in France

Mexico8 sites

  • Investigational Site Number : 4840010

    Cuernavaca, Morelos, 62290

  • Investigational Site Number : 4840001

    México, 04530

  • Investigational Site Number : 4840006

    México, 06720

  • Investigational Site Number : 4840003

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840009

    Monterrey, Nuevo León, 64460

  • Investigational Site Number : 4840008

    Monterrey, Nuevo León, 64718

  • Investigational Site Number : 4840004

    Puebla City, 72190

  • Investigational Site Number : 4840005

    Tlalnepantla, 54055

Other trials in Mexico

South Korea7 sites

  • Investigational Site Number : 4100008

    Ansan-si, Gyeonggi-do, 15355

  • Investigational Site Number : 4100007

    Incheon, Incheon-gwangyeoksi, 21565

  • Investigational Site Number : 4100001

    Seoul, 01757

  • Investigational Site Number : 4100003

    Seoul, 02447

  • Investigational Site Number : 4100005

    Seoul, 05505

  • Investigational Site Number : 4100004

    Seoul, 06351

  • Investigational Site Number : 4100002

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Spain7 sites

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08950

  • Investigational Site Number : 7240011

    Barcelona, 08003

  • Investigational Site Number : 7240002

    Barcelona, 08041

  • Investigational Site Number : 7240003

    Madrid, 28007

  • Investigational Site Number : 7240010

    Madrid, 28041

  • Investigational Site Number : 7240009

    Mieres, Principality of Asturias, 33611

  • Investigational Site Number : 7240012

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

Australia6 sites

  • Investigational Site Number : 0360008

    Kogarah, New South Wales, 2217

  • Investigational Site Number : 0360010

    Melbourne, Victoria, 3128

  • Investigational Site Number : 0360003

    Parkville, Victoria, 3052

  • Investigational Site Number : 0360007

    Richmond, Victoria, 3121

  • Investigational Site Number : 0360011

    Sydney, New South Wales, 2010

  • Investigational Site Number : 0360009

    Sydney, New South Wales, 2560

Other trials in Australia

Israel5 sites

  • Investigational Site Number : 3760003

    Beersheba, 8457108

  • Investigational Site Number : 3760004

    Haifa, 3104802

  • Investigational Site Number : 3760005

    Kefar Sava, 4428164

  • Investigational Site Number : 3760001

    Ramat Gan, 5262100

  • Investigational Site Number : 3760002

    Rehovot, 7610001

Other trials in Israel

Netherlands5 sites

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ

  • Investigational Site Number : 5280005

    Groningen, 9713 GR

  • Investigational Site Number : 5280002

    Rotterdam, 3015 CE

  • Investigational Site Number : 5280006

    The Hague, 2566 MJ

  • Investigational Site Number : 5280003

    Utrecht, 3508 GA

Other trials in Netherlands

Russia5 sites

  • Investigational Site Number : 6430005

    Moscow, 109240

  • Investigational Site Number : 6430002

    Moscow, 115478

  • Investigational Site Number : 6430003

    Moscow, 117513

  • Investigational Site Number : 6430001

    Moscow, 119991

  • Investigational Site Number : 6430004

    Moscow, 125373

Other trials in Russia

Greece4 sites

  • Investigational Site Number : 3000004

    Larissa, 411 10

  • Investigational Site Number : 3000005

    Thessaloniki, 54642

  • Investigational Site Number : 3000003

    Thessaloniki, 54643

  • Investigational Site Number : 3000002

    Thessaloniki, 564 29

Other trials in Greece

Portugal4 sites

  • Investigational Site Number : 6200003

    Braga, 4710-243

  • Investigational Site Number : 6200005

    Lisbon, 1169-050

  • Investigational Site Number : 6200001

    Lisbon, 1649-035

  • Investigational Site Number : 6200006

    Porto, 4200-319

Other trials in Portugal

Colombia3 sites

  • Investigational Site Number : 1700006

    Barranquilla, 080002

  • Investigational Site Number : 1700001

    Bogotá, 110111

  • Investigational Site Number : 1700004

    Bogotá, 111211

Other trials in Colombia

Norway3 sites

  • Investigational Site Number : 5780001

    Bergen, 5021

  • Investigational Site Number : 5780002

    Oslo, 0027

  • Investigational Site Number : 5780003

    Stavanger, 4011

Other trials in Norway

Denmark1 site

  • Investigational Site Number : 2080002

    København NV, 2400

Other trials in Denmark

About this study

Official title: Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Primary Objectives:

  • To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
  • To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

  • To characterize disease burden and unmet need.
  • To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
  • To document the real-world effectiveness and safety of treatments.
Read the detailed description

The study duration is 120 months.

Being tested
Standard of care
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of careOther

    Treatment as per standard practice

Study groups in NCT03687359
Study groupRoleWhat they receive
Participants with atopic dermatitis (AD)Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study.
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient demographics

    Measured: Baseline (Month 0)

  2. Medical history of selected atopic diseases and comorbidities

    Measured: Baseline (Month 0)

  3. Age at onset of atopic dermatitis (AD)

    Measured: Baseline (Month 0)

  4. Personal and family history of AD and selected atopic diseases

    Measured: Baseline (Month 0)

  5. All prior and current systemic AD treatment

    Measured: Baseline (Month 0)

  6. All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)

    Measured: Baseline (Month 0)

  7. Presence/severity of AD and selected atopic comorbid conditions

    Measured: Baseline to Month 120

  8. Therapy for selected atopic comorbid conditions

    Measured: Baseline to Month 120

Secondary outcomes (15)

  1. Days missed from school for the patient and days missed from work for the primary caregiver due to AD

    Measured: Baseline to Month 120

  2. Visits to healthcare professionals (HCPs)

    Measured: Baseline to Month 120

  3. Treatments and prescribing patterns for pediatric AD

    Measured: Baseline to Month 120

  4. Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])

    Measured: Baseline to Month 120

  5. Changes in physician assessment of disease burden (Body Surface Area [BSA])

    Measured: Baseline to Month 120

  6. Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)

    Measured: Baseline to Month 120

  7. Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)

    Measured: Baseline to Month 120

  8. Change in PRO: Dermatitis Family Impact (DFI)

    Measured: Baseline to Month 120

  9. Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS

    Measured: Baseline to Month 120

  10. Change in PRO: Caregiver Global Assessment of Disease (CGAD)

    Measured: Baseline to Month 120

  11. Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit

    Measured: Baseline to Month 120

  12. Change in PRO: Total Nasal Symptom Score (TNSS)

    Measured: Baseline to Month 120

  13. Change in PRO: Pediatric Asthma Questionnaire (PAQ)

    Measured: Baseline to Month 120

  14. Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)

    Measured: Baseline to Month 120

  15. Adverse event (AE) reporting

    Measured: Baseline to Month 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start15 Aug 2019
  3. Primary completion23 Jul 2035 (estimated)
  4. Study completion23 Jul 2035 (estimated)

Resources

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
1,860 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687359
Sponsor's protocol ID
OBS15333
Other IDs
U1111-1211-9437
Acronym
PEDISTAD
Status last verified
Aug 2025
First submitted
6 Sep 2018
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Paller AS, Irvine AD, Baselga E, de Graaf M, Siegfried EC, Cork MJ, Ramien M, Eichenfield LF, Adams B, Gupta R, Ardeleanu M, Zhang A. Growth Assessment in Children Under 12 Years With Moderate-to-Severe Atopic Dermatitis Included in the PEDISTAD Observational Registry. Pediatr Dermatol. 2026 Aug 18. doi: 10.1111/pde.70335. Online ahead of print.

    PubMed 42609208

  • Paller AS, Marcoux D, Ramien M, Baselga E, Carvalho VO, Ardusso LRF, de Graaf M, Pasmans S, Toledo-Bahena M, Rubin C, Joyce JC, Lee LW, Gupta R, Adams B, Ardeleanu M, Zhang A. Systemic Treatments in Moderate-to-Severe Atopic Dermatitis in Pediatric Patients up to 12 Years of Age: Real-World Treatment Outcomes from the PEDISTAD Registry. Am J Clin Dermatol. 2025 Nov;26(6):1031-1043. doi: 10.1007/s40257-025-00962-8. Epub 2025 Sep 19.

    PubMed 40971133

  • Paller AS, de Bruin-Weller M, Marcoux D, Baselga E, Oliveira de Carvalho V, Ardusso LRF, Pasmans SGMA, Toledo-Bahena M, Rubin C, Joyce JC, Wine Lee L, Adams B, Gupta R, Ardeleanu M, Zhang A. Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDIatric STudy in Atopic Dermatitis. J Am Acad Dermatol. 2025 Feb;92(2):242-251. doi: 10.1016/j.jaad.2024.09.046. Epub 2024 Oct 9.

    PubMed 39389429

  • Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.

    PubMed 32209624

Questions about this trial

What is this clinical trial studying?

An observational study of Dermatitis Atopic, run by Sanofi at 182 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Japan, Italy, Argentina, China and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient demographics (time frame: Baseline (Month 0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687359, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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