A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Lilly

Status and phase: Terminated; Phase 1

Conditions: Psoriasis

Treatments: Drug: LY3462817 - IV; Drug: LY3462817 - SC; Drug: LY3509754; Drug: Placebo - SC; Drug: Placebo - IV; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04152382

17218

J1A-MC-KDAC (Other Identifier)

Details and patient eligibility

About

This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have been diagnosed with psoriasis for at least 6 months
• Participants must have active psoriasis plaques
• Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)

Exclusion criteria

• Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1)
• Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 6 patient groups, including a placebo group

LY3462817 - Intravenous (IV)

Experimental group

Description:

LY3462817 administered as IV infusions.

Treatment:

Drug: LY3462817 - IV

Placebo - IV

Placebo Comparator group

Description:

Placebo administered as IV infusions.

Treatment:

Drug: Placebo - IV

LY3462817 - Subcutaneous (SC)

Experimental group

Description:

LY3462817 administered as SC injections. (SC administration is discretionary/optional.)

Treatment:

Drug: LY3462817 - SC

Placebo - SC

Placebo Comparator group

Description:

Placebo administered as SC injections. (SC administration is discretionary/optional.)

Treatment:

Drug: Placebo - SC

LY3509754

Experimental group

Description:

LY3509754 administered orally.

Treatment:

Drug: LY3509754

Placebo

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo