Dermatitis, AtopicPhase 1NCT03750643
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
A Phase 1 study testing LY3454738 in people with Dermatitis, Atopic, run by Eli Lilly and Company at 21 sites in 2 countries.
Trial summary
The main purpose of this study is to investigate the safety, tolerability, and efficacy of the study drug known as LY3454738 in healthy participants and participants with atopic dermatitis. The study has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- LY3454738
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 29 Nov 2018to 7 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All: Must have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, for Parts A and B, and 18.0 to 45.0 kg/m², inclusive, for Part C and a minimum body weight of 50 kilograms
- For PART A and B only, regarding the inclusion of healthy Japanese participants: Minimum age is 20 years and the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent and must have been born in Japan
- AD:
- Must have a diagnosis of AD for at least 12 months with either poor response to topical treatments or inability to use topical treatments
- Must agree to use moisturizer daily throughout the treatment period
Who cannot join
- All: must not have previously completed a clinical trial with a molecule targeting interleukin-33 (IL-33) or its receptor
- AD:
- Must not have received certain topical medications for AD within 2 weeks prior to randomization
- Must not have received certain oral medications for AD or received phototherapy within 4 weeks prior to randomization
- Must not have received any antibody-based biologic agents (marketed or investigational) within 5 half lives (t1/2) of the drug prior to randomization
- Must not have received intravenous, intramuscular, or intra-articular steroids in the past 6 weeks prior to randomization
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Pinnacle Research Group
Anniston, Alabama, 36207
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225
Wright State Physicians Dermatology
Dayton, Ohio, 46435
Revival Research Corporation
Doral, Florida, 33122
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
First OC Dermatology
Fountain Valley, California, 92708
California Clinical Trials Medical Group
Glendale, California, 91206
Center for Clinical Studies
Houston, Texas, 77004
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Global Health Research Center
Miami Lakes, Florida, 33016
JUVA Skin & Laser Center
New York, New York, 10022-3350
Central Sooner Research
Norman, Oklahoma, 73071
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Wake Research Associates
Raleigh, North Carolina, 27612
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Progressive Clinical Research
San Antonio, Texas, 78213
Premier Clinical Research
Spokane, Washington, 99202
ForCare Clinical Research
Tampa, Florida, 33613-1244
Palm Beach Research Center
West Palm Beach, Florida, 33409
Puerto Rico2 sites
Dermatology
Los Prados, Caguas, 00727
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, 00917
About this study
Official title: Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis
The main purpose of this study is to investigate the safety, tolerability, and efficacy of the study drug known as LY3454738 in healthy participants and participants with atopic dermatitis. The study has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part.
- Conditions
- Dermatitis, Atopic
- Being tested
- LY3454738, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3454738Drug
Administered IV
LY3454738Drug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3454738 - Part A | Experimental | Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants Receives: Drug: LY3454738 |
| Placebo - Part A | Placebo comparator | Placebo administered IV to healthy participants Receives: Drug: Placebo |
| LY3454738 - Part B | Experimental | LY3454738 administered IV to healthy participants Receives: Drug: LY3454738 |
| Placebo - Part B | Placebo comparator | Placebo administered IV to healthy participants Receives: Drug: Placebo |
| LY3454738 - Part C | Experimental | LY3454738 administered IV to participants with atopic dermatitis (AD) Receives: Drug: LY3454738 |
| Placebo - Part C | Placebo comparator | Placebo administered IV to participants with AD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to Week 24
Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline
The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification
Measured: Week 12
Secondary outcomes (2)
Maximum Observed Drug Concentration (Cmax) of LY3454738
Cmax of LY3454738
Measured: Day 1 through Day 85 (Day 99 for Part C)
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
AUC of LY3454738
Measured: Day 1 through Day 85 (Day 99 for Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start29 Nov 2018
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750643
- Sponsor's protocol ID
- 17090
- Other IDs
- J1B-MC-FRCC
- Status last verified
- 1 Oct 2021
- First submitted
- 20 Nov 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Multicenter, Randomized, Placebo-Controlled, Triple-Blind, Single-Ascending Dose and Repeat-Dose Trial in Healthy Participants and Participants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03750643
- Acronym / sponsor ID
- 17090
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 23 Nov 2018 (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 investigate the safety, tolerability, and efficacy of the study drug known as LY3454738 in healthy participants and participants with atopic dermatitis. The study has three parts. Each participant will enroll in one part. The study will last 12 to 24 weeks, depending on part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3454738 - Part A | Experimental | Drug: LY3454738Escalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants |
| Placebo - Part A | Placebo comparator | Drug: PlaceboPlacebo administered IV to healthy participants |
| LY3454738 - Part B | Experimental | Drug: LY3454738LY3454738 administered IV to healthy participants |
| Placebo - Part B | Placebo comparator | Drug: PlaceboPlacebo administered IV to healthy participants |
| LY3454738 - Part C | Experimental | Drug: LY3454738LY3454738 administered IV to participants with atopic dermatitis (AD) |
| Placebo - Part C | Placebo comparator | Drug: PlaceboPlacebo administered IV to participants with AD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All: Must have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, for Parts A and B, and 18.0 to 45.0 kg/m², inclusive, for Part C and a minimum body weight of 50 kilograms
- For PART A and B only, regarding the inclusion of healthy Japanese participants: Minimum age is 20 years and the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent and must have been born in Japan
- AD:
Key exclusion criteria (6 listed)
- All: must not have previously completed a clinical trial with a molecule targeting interleukin-33 (IL-33) or its receptor
- AD:
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 |
|---|---|---|
| LY3454738Administered IV | Drug | LY3454738 - Part A, LY3454738 - Part B, LY3454738 - Part C |
| LY3454738Administered SC | Drug | LY3454738 - Part A |
| PlaceboAdministered IV | Drug | Placebo - Part A, Placebo - Part B, Placebo - Part C |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 24
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline
Time frame: Week 12
The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification
2 secondary outcomes
Maximum Observed Drug Concentration (Cmax) of LY3454738
Time frame: Day 1 through Day 85 (Day 99 for Part C)
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
Time frame: Day 1 through Day 85 (Day 99 for Part C)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis (Eczema)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3454738 in people with Dermatitis, Atopic, run by Eli Lilly and Company at 21 sites in 2 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 24). The study lists 2 primary outcomes in all. 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 6 Oct 2021.