Dermatitis, AtopicPhase 1NCT04081350
A Study of LY3471851 in Participants With Eczema
A Phase 1 study testing LY3471851 in people with Dermatitis, Atopic, run by Nektar Therapeutics at 20 sites in United States.
Trial summary
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- LY3471851
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 20 sitesUnited States
- Study dates
- 4 Dec 2019to 24 Jun 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
- Have active AD according to study specific criteria
- Be willing and able to undergo skin biopsies
Who cannot join
- Have received certain topical medications for AD within 14 days prior to baseline
- Have received certain systemic medications for AD within 4 weeks prior to baseline
- Have received LY3471851 previously
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Remington-Davis, Inc
Columbus, Ohio, 43215
Studies in Dermatology, LLC
Cypress, Texas, 77433
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Rodgers Dermatology
Frisco, Texas, 75034
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Skin Sciences
Louisville, Kentucky, 40217
Miami Dermatology and Laser Research
Miami, Florida, 33173
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801
Progressive Clinical Research
San Antonio, Texas, 78213
Therapeutics Clinical Research
San Diego, California, 92123
Medical Dermatology Specialists
Sandy Springs, Georgia, 30328
Clinical Science Institute
Santa Monica, California, 90404
Complete Dermatology
Sugar Land, Texas, 77478
DermDox Centers for Dermatology
Sugarloaf, Pennsylvania, 18249
ForCare Clinical Research
Tampa, Florida, 33613-1244
Derm Center
Troy, Michigan, 48084
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
- Conditions
- Dermatitis, Atopic
- Being tested
- LY3471851, 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.
LY3471851Drug
Also called NKTR-358
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 10 µg/kg LY3471851 | Active comparator | Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. Receives: Drug: LY3471851 |
| 12 µg/kg LY3471851 | Active comparator | Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. Receives: Drug: LY3471851 |
| 24 µg/kg LY3471851 | Active comparator | Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. Receives: Drug: LY3471851 |
| Placebo | Placebo comparator | Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks. 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 through Study Completion (up to Week 48)
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
PK: AUC of LY3471851
Measured: Postdose on Day 1 through Day 14
PK: Trough Concentrations (Ctrough) of LY3471851
PK: Ctrough of LY3471851
Measured: Week 12
PK: Maximum Concentration (Cmax) of LY3471851
PK: Cmax of LY3471851
Measured: Postdose on Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start4 Dec 2019
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081350
- Sponsor's protocol ID
- 17240
- Other IDs
- J1P-MC-KFAD
- Status last verified
- 15 Feb 2024
- First submitted
- 5 Sep 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1.
PubMed 39455575
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04081350
- Acronym / sponsor ID
- 17240
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 9 Sep 2019 (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 learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 µg/kg LY3471851 | Active comparator | Drug: LY3471851Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 12 µg/kg LY3471851 | Active comparator | Drug: LY3471851Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| 24 µg/kg LY3471851 | Active comparator | Drug: LY3471851Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
- Have active AD according to study specific criteria
- Be willing and able to undergo skin biopsies
Key exclusion criteria (3 listed)
- Have received certain topical medications for AD within 14 days prior to baseline
- Have received certain systemic medications for AD within 4 weeks prior to baseline
- Have received LY3471851 previously
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 |
|---|---|---|
| LY3471851Also: NKTR-358Administered SC | Drug | 10 µg/kg LY3471851, 12 µg/kg LY3471851, 24 µg/kg LY3471851 |
| PlaceboAdministered SC | Drug | Placebo |
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 through Study Completion (up to Week 48)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Time frame: Postdose on Day 1 through Day 14
PK: Trough Concentrations (Ctrough) of LY3471851
Time frame: Week 12
PK: Maximum Concentration (Cmax) of LY3471851
Time frame: Postdose on Day 1 through Day 14
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 20 Feb 2024.
- Derived from this study: PubMed 39455575Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1.
- A Study of LY3471851 in Participants With EczemaLink 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.
Study Director study director
Nektar Therapeutics
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3471851 in people with Dermatitis, Atopic, run by Nektar Therapeutics at 20 sites in United States.
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 3 inclusion and 3 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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 through Study Completion (up to Week 48)). 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 NCT04081350, which also lists 1 linked publication.
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 20 Feb 2024.