A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 3/21/2019 |
Start Date: | January 30, 2018 |
End Date: | September 2, 2019 |
A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis
The purpose of this study is to evaluate how well LY3316531 is tolerated and what side
effects may occur in healthy participants and participants with psoriasis. The study drug
will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into
a vein in the arm).
This is a three-part study. Participants will enroll in only one part. Parts A and B are for
healthy participants and Part C is for participants with psoriasis. Participation could last
between 16 and 57 weeks.
effects may occur in healthy participants and participants with psoriasis. The study drug
will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into
a vein in the arm).
This is a three-part study. Participants will enroll in only one part. Parts A and B are for
healthy participants and Part C is for participants with psoriasis. Participation could last
between 16 and 57 weeks.
Inclusion Criteria:
- Healthy Participants
- Are overtly healthy males or females, as determined by medical history and
physical examination
- Females must be of non-childbearing potential
- Are between 18 and 64 years of age, inclusive, at screening
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²)
inclusive
- Are reliable and willing to make themselves available for the duration of the
study and are willing to follow study procedures
- Psoriasis Participants:
- Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic
psoriasis vulgaris for at least 6 months prior to baseline
- Meet psoriasis disease activity criteria
- Are at least 18 years of age
- Have a minimum body weight of 50 kilograms (kg)
Exclusion Criteria:
- Healthy and Psoriasis Participants
- Have known or ongoing neuropsychiatric disorders
- Have received live vaccine(s) (included attenuated live vaccines) within 28 days
of screening or intend to during the study
- Have had any malignancy within the past 5 years except for basal cell or squamous
cell epithelial carcinomas of the skin that have been resected with no subsequent
evidence of recurrence for at least 3 years prior to screening and cervical
carcinoma in situ with no evidence of recurrence within 5 years prior to baseline
- Show evidence of active or latent tuberculosis (TB)
- Have presence of significant uncontrolled cerebro-cardiovascular, respiratory,
hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or
neuropsychiatric disorders or abnormal laboratory values at screening that, in
the opinion of the investigator, pose an unacceptable risk to the participant if
participating in the study or of interfering with the interpretation of data
- Psoriasis Participants Only:
- Have received treatment with biologic therapies for psoriasis (such as monoclonal
antibodies, including marketed or investigational biologic therapy)
- Prior or current use of biologics for indications other than psoriasis may be
allowed with sponsor approval
- Have received systemic nonbiologic psoriasis therapy within 28 days of baseline
- Have received topical psoriasis treatment within 14 days of baseline
We found this trial at
2
sites
Baltimore, Maryland 21225
Principal Investigator: Azra Hussaini
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Glendale, California 91206
Principal Investigator: Hakop Gevorkyan
Phone: 818-254-1600
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