A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis

Lilly

Status and phase: Terminated; Phase 1

Conditions: Dermatitis, Atopic; Healthy

Treatments: Drug: LY3844583; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05486208

18365

J3V-MC-KKAA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD). The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis. The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 85, 113, and 183 days with 10, 18, and 14 visits for each participant in parts A, B, and C, respectively.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants (Parts A and B):

  • Are male or female not of childbearing potential
  • Inclusion of healthy Japanese participants, the participant must be first-generation Japanese, defined as 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.
  • Inclusion of healthy Chinese participants, the participant must be at a minimum, third-generation Chinese, defined as all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China.
  • Must have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive. For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m², inclusive, and a body weight of 50 kg to 85 kg, inclusive.

• Atopic dermatitis participants (Part C):

  • Must have a body mass index of 18.0 to 45.0 kg/m², inclusive
  • Are male or female participants including those of child bearing potential
  • Must have a diagnosis of AtD 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

Exclusion criteria

• All participants:

  • Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Have active or latent tuberculosis
  • Have had any cancer within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline
  • Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 30 days or 5 half-lives (whichever is longer) prior to dosing
  • Must not have previously completed a clinical trial with a molecule targeting interleukin-33 and/or the interleukin-33 receptor (ST2)
  • Are currently participating in or completed a clinical trial within the last 30 days
  • Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study

• Atopic dermatitis participants:

  • Must not have received certain topical medications for AtD within 2 weeks prior to randomization
  • Must not have received certain oral medications for AtD 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 12 patient groups, including a placebo group

Part A: Placebo SC (Single Ascending Dose [SAD] - Cohort 1-3)

Placebo Comparator group

Description:

Healthy participants received a single matching dose of Placebo via subcutaneous (SC) injection on Day 1.

Treatment:

Drug: Placebo

Drug: Placebo

Part A: Placebo IV (SAD - Cohort 4-5)

Placebo Comparator group

Description:

Healthy participants received a single matching dose of Placebo via intravenous (IV) infusion on Day 1.

Treatment:

Drug: Placebo

Drug: Placebo

Part A: 30 mg LY3844583 SC (SAD - Cohort 1)

Experimental group

Description:

Healthy participants received a single dose of 30 milligrams (mg) LY3844583 via SC injection on Day 1.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part A: 100 mg LY3844583 SC (SAD - Cohort 2)

Experimental group

Description:

Healthy participants received a single dose of 100 mg LY3844583 via SC injection on Day 1.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part A: 300 mg LY3844583 SC (SAD - Cohort 3)

Experimental group

Description:

Healthy participants received a single dose of 300 mg LY3844583 via SC injection on Day 1.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part A: 300 mg LY3844583 IV (SAD - Cohort 4)

Experimental group

Description:

Healthy participants received a single dose of 300 mg LY3844583 via IV infusion on Day 1.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part A: 1000 mg LY3844583 IV (SAD - Cohort 5)

Experimental group

Description:

Healthy participants received a single dose of 1000 mg LY3844583 via IV infusion on Day 1.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part B: Placebo IV (Multiple Ascending Dose [MAD] - Cohort 1-2)

Experimental group

Description:

Healthy participants received a matching dose of Placebo via IV infusion once every 2 weeks (Q2W) on Days 1, 15, and 29 in Cohort 1, or once every week (QW) on Days 1, 8, 15, 22, and 29 in Cohort 2.

Treatment:

Drug: Placebo

Drug: Placebo

Part B: 300 mg LY3844583 IV Q2W (MAD - Cohort 1)

Experimental group

Description:

Healthy participants received 300 mg LY3844583 via IV infusion Q2W on Days 1, 15, and 29.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part B: 1000 mg LY3844583 IV QW (MAD - Cohort 2)

Experimental group

Description:

Healthy participants received 1000 mg LY3844583 via IV infusion QW on Days 1, 8, 15, 22, and 29.

Treatment:

Drug: LY3844583

Drug: LY3844583

Part C: Placebo IV Q2W

Experimental group

Description:

Participants with Atopic Dermatitis (AtD) received a matching dose of Placebo via IV infusion Q2W for 12 weeks.

Treatment:

Drug: Placebo

Drug: Placebo

Part C: 1000 mg LY3844583 IV Q2W (Cohort 1)

Experimental group

Description:

Participants with AtD received 1000 mg LY3844583 via IV infusion Q2W for 12 weeks.

Treatment:

Drug: LY3844583

Drug: LY3844583