A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

• ClinicalTrials.gov Identifier: NCT05984784
• Recruitment Status: Terminated
• First Posted: August 9, 2023
• Last Update Posted: May 16, 2024
• Sponsor: Inmagene LLC
• Information provided by (Responsible Party): Inmagene LLC

Tracking Information

• First Submitted Date: July 25, 2023
• First Posted Date: August 9, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: August 9, 2023
• Actual Primary Completion Date: April 26, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2023)

Evaluation of Adverse Events in Participants [ Time Frame: Baseline, Week 24 ]

To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 2, 2023)

• Pharmacokinetic Characterization [ Time Frame: Baseline, Week 24 ]
  To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants
• Pharmacokinetic Characterization [ Time Frame: Baseline, Week 24 ]
  To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants
• Evaluation of Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 12 ]
  To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)
• Official Title: A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
• Brief Summary: The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
• Detailed Description: This is a phase 1b/2a study to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with AD. The study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. Cohort 1 is open-label, with approximately 15 participants to receive three IV infusions of IMG-007 Dose 1 over 4 weeks. Cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three IV infusions of IMG-007 Dose 2 or matching placebo over 4 weeks.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Atopic Dermatitis
• Moderate-to-severe Atopic Dermatitis
• AD

Intervention

• Drug: Placebo
  Drug: Placebo Intravenous Infusion
• Drug: IMG-007
  Drug: IMG-007 Intravenous Infusion

Study Arms

• Experimental: IMG-007 Dose 1
  IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
  Intervention: Drug: IMG-007
• Experimental: IMG-007 Dose 2
  IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
  Intervention: Drug: IMG-007
• Placebo Comparator: Placebo
  Placebo will be administered intravenously 3 times over 4 weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 15, 2024): 13
• Original Estimated Enrollment (submitted: August 2, 2023): 24
• Actual Study Completion Date: April 26, 2024
• Actual Primary Completion Date: April 26, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Male or female aged ≥ 18 and < 75 years.
• Moderate-to-severe AD.
• Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable.
• Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.

Key Exclusion Criteria:

• Known hepatitis B, hepatitis C, or human immunodeficiency virus infection.
• Evidence of active or latent tuberculosis (TB).
• History of untreated or inadequately treated TB infection.
• Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit.
• Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement.
• Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT05984784
• Other Study ID Numbers: IMG-007-201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Inmagene LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Inmagene LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Inmagene LLC
• Verification Date: May 2024