Psoriasis Clinical Trial
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 Psoriasis
| Verified date | February 2024 |
| Source | Nektar Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main purpose of this study is to learn more about the safety of LY3471851 when given by injection just under the skin to participants with psoriasis. The study will last up to 48 weeks and may include up to 23 visits to the study center.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | July 21, 2021 |
| Est. primary completion date | July 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Have a confirmed diagnosis of psoriasis for at least 6 months - Have active psoriasis plaques according to study- specific criteria - Be willing and able to undergo skin biopsies Exclusion Criteria: - Have received certain topical medications for psoriasis within 14 days prior to baseline - Have received certain systemic medications for psoriasis within 4 weeks prior to baseline - Have received LY3471851 previously |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
| United States | Remington-Davis, Inc | Columbus | Ohio |
| United States | Florida Academic Centers Research and Education, LLC | Coral Gables | Florida |
| United States | Studies in Dermatology, LLC | Cypress | Texas |
| United States | California Dermatology & Clinical Research Institute | Encinitas | California |
| United States | Center For Dermatology Clinical Research, Inc. | Fremont | California |
| United States | Rodgers Dermatology | Frisco | Texas |
| United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
| United States | Forefront Research | Louisville | Kentucky |
| United States | Skin Sciences | Louisville | Kentucky |
| United States | Miami Dermatology and Laser Research | Miami | Florida |
| United States | Arkansas Research Trials, LLC | North Little Rock | Arkansas |
| United States | Unity Clinical Research | Oklahoma City | Oklahoma |
| United States | Paddington Testing Company Inc | Philadelphia | Pennsylvania |
| United States | ActivMed Practices and Research | Portsmouth | New Hampshire |
| United States | Central Dermatology PC | Saint Louis | Missouri |
| United States | Progressive Clinical Research | San Antonio | Texas |
| United States | Therapeutics Clinical Research | San Diego | California |
| United States | Medical Dermatology Specialists | Sandy Springs | Georgia |
| United States | Clinical Science Institute | Santa Monica | California |
| United States | Complete Dermatology | Sugar Land | Texas |
| United States | DermDox Centers for Dermatology | Sugarloaf | Pennsylvania |
| United States | ForCare Clinical Research | Tampa | Florida |
| United States | Derm Center | Troy | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Nektar Therapeutics | Eli Lilly and Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Baseline through Study Completion (up to Week 48) | |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | PK: AUC of LY3471851 | Postdose on Day 1 through Day 14 | |
| Secondary | PK: Trough Concentrations (Ctrough) of LY3471851 | PK: Ctrough of LY3471851 | Week 12 | |
| Secondary | PK: Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Postdose on Day 1 through Day 14 |
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