Atopic DermatitisPhase 3ADorable-2NCT05735483
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis and Eczema, run by Eli Lilly and Company at 94 sites in 13 countries.
Trial summary
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 94 sitesin 13 countries
- Study dates
- 9 Mar 2023to Apr 2029
- Phase
- Phase 3
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
- For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Who cannot join
- Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
- Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
- Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
Trial locations and contacts
94 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
94 sites in 13 countries
United States21 sites
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Treasure Valley Medical Research
Boise, Idaho, 83706
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Wright State Physicians
Fairborn, Ohio, 45324
UConn Health
Farmington, Connecticut, 06030
First OC Dermatology
Fountain Valley, California, 92708
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Dermatology Research Associates
Los Angeles, California, 90045
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Arkansas Research Trials
North Little Rock, Arkansas, 72217
Allergy and Asthma Specialist
Owensboro, Kentucky, 42301
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Integrative Skin Science and Research - Location 2
Sacramento, California, 95815
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
ForCare Clinical Research
Tampa, Florida, 33613
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
Japan12 sites
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510
Fukuyama City Hospital
Fukuyama, Hiroshima, 721-8511
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Ina Central Hospital
Ina, Nagano, 396-0033
Enomoto Clinic
Kumagaya, Saitama, 360-0018
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, 252-0315
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, 593-8324
Sugamo Sengoku Dermatology
Toshima City, Tokyo, 170-0002
Fujita Health University
Toyoake, Aichi-ken, 470-1192
Spain10 sites
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Hospital Universitario de Gran Canaria Doctor Negrín
Las, Las Palmas, 35010
Grupo Pedro Jaén
Madrid, Madrid, 28006
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, 28009
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital de Manises
Manises, València, 46940
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], 36001
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Mexico9 sites
Scientia Investigacion Clinica S.C.
Chihuahua City, Chihuahua, 31207
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, Morelos, 62290
Hospital de Jesús Nazareno
Mexico City, Mexico City, 06090
Trials in Medicine
Mexico City, Mexico City, 06700
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, 06720
Eukarya PharmaSite
Monterrey, Nuevo León, 64718
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Arké SMO S.A de C.V
Veracruz, Veracruz, 91910
Instituto Dermatologico de Jalisco
Zapopan, Jalisco, 45190
Brazil8 sites
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, Rio de Janeiro, 20241-180
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870
Pesquisare Saude
Santo André, São Paulo, 09080-110
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425
Argentina7 sites
CONEXA Investigacion Clinica S.A.
Buenos Aires, Buenos Aires, 1012
Fundación Respirar
Buenos Aires, Buenos Aires, C1426ABP
Fundacion Cidea
Buenos Aires, Buenos Aires F.D., C1121ABE
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1425
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1425DKG
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Taiwan6 sites
National Taiwan University Hospital - Hsinchu branch
Hsinchu, Hsinchu, 300
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Chung Shan Medical University Hospital
Taichung, Taichung, 402
National Taiwan University Hospital
Taipei, Taipei, 10002
Taipei Veterans General Hospital
Taipei, Taipei, 11217
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taoyuan, 333
Germany5 sites
Fachklinik Bad Bentheim
Bad Bentheim, Niedersach, 48455
Rosenpark Research GmbH
Darmstadt, Hesse, 64283
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Australia4 sites
Cornerstone Dermatology
Coorparoo, Queensland, 4151
Sydney Children's Hospital
Randwick, New South Wales, 2031
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
France4 sites
Hôpital Saint Vincent-de-Paul
Lille, Hauts-de-France, 59020
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093 Cedex 1
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, 26102
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, 31400
Poland4 sites
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Diamond Clinic
Krakow, Małopolski, 31-559
DERMED Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, 02-625
Canada2 sites
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Czechia2 sites
Detska nemocnice FN Brno
Brno, Brno-město, 613 00
Fakultni nemocnice Bulovka
Prague, Praha 8, 180 81
About this study
Official title: A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis.
This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Lebrikizumab, Placebo
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Also called LY3650150
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab | Experimental | Participants will receive Lebrikizumab administered subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. Receives: Drug: Lebrikizumab; Drug: Placebo |
| Lebrikizumab - Optional Extension Period (OEP) | Experimental | During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52. Receives: Drug: Lebrikizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Measured: Baseline through Week 52
Secondary outcomes (9)
Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ
Measured: Baseline to Week 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
Measured: Baseline to Week 52
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
Measured: Baseline to Week 52
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ
Measured: Baseline to Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
Measured: Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
Measured: Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Measured: Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Measured: Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735483
- Sponsor's protocol ID
- 18266
- Other IDs
- J2T-MC-KGBJ/DRM06-AD16, 2022-501478-21-00
- Acronym
- ADorable-2
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05735483
- Acronym / sponsor ID
- ADorable-2 / 18266
- Conditions
- Atopic Dermatitis, Eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis.
This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab | Experimental | Drug: Lebrikizumab, Drug: PlaceboParticipants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. |
| Lebrikizumab - Optional Extension Period (OEP) | Experimental | Drug: Lebrikizumab, Drug: PlaceboDuring the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
- For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Key exclusion criteria (5 listed)
- Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
- Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
- Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LebrikizumabAlso: LY3650150Administered SC | Drug | Lebrikizumab, Lebrikizumab - Optional Extension Period (OEP) |
| PlaceboAdministered SC | Drug | Lebrikizumab, Lebrikizumab - Optional Extension Period (OEP) |
Primary outcome
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Time frame: Baseline through Week 52
9 secondary outcomes
Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ
Time frame: Baseline to Week 52
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
Time frame: Baseline to Week 52
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
Time frame: Baseline to Week 52
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ
Time frame: Baseline to Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
Time frame: Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
Time frame: Baseline, Week 52
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Time frame: Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Time frame: Baseline, Week 52
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
Time frame: Baseline, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to \<18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Active, not recruitingPhase 2
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
94 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis and Eczema, run by Eli Lilly and Company at 94 sites in 13 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 5 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Japan, Spain, Mexico, Brazil and 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) (time frame: Baseline through Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.