A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis - IMG-007-201

Inmagene LLC0 sites55 target enrollmentNovember 14, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Inmagene LLC
Enrollment: 55
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 14, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Inmagene LLC

Eligibility Criteria

Inclusion Criteria

•1\) Male or female aged \= 18 and \< 75 years., 2\) Voluntarily signed informed consent to participate in the study, 3\) Diagnosed with AD for \= 6 months according to the American Academy of Dermatology Consensus diagnostic criteria at the Screening visit., 4\) Moderate\-to\-severe AD, defined as: a) EASI score \= 12 at the Screening visit and \= 16 at the Baseline visit b) IGA \= 3 at the Screening visit and the Baseline visit c) Body surface area (BSA) \= 10% at the Screening visit and the Baseline visit, 5\) Documented history of inadequate response or lack of tolerability or for whom topical treatments are otherwise inadvisable., 6\) Agree to apply a stable dose of a non\-medicated emollient (moisturizer)., 7\) Female participants who are not pregnant or breastfeeding, or female of childbearing potential who agrees to use a highly effective method of contraception or to practice true abstinence during the study, 8\) Male participants must agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potential. Other protocol defined inclusion criteria might apply

Exclusion Criteria

•1\) Severe systemic diseases that could increase the risk associated with study participation or could interfere with the interpretation of study results and would make the patient inappropriate for entry into the study. Please refer to the Protocol for more information on the Exclusion criteria No.1\., 10\) Use of non\-biologic systemic (oral or injectable) agents including conventional immunosuppressants or immunomodulators and other approved drugs, within 4 weeks or 5 half\-lives prior to the Baseline (Day 1\) visit., 11\) Use of biologic therapy including approved and investigational agents within 3 months or 5 half\-lives, prior to the Baseline (Day 1\) visit., 12\) Receipt of a live (including live attenuated) vaccine within 2 months prior to the Baseline (Day 1\) visit (participants must agree to avoid (including live attenuated) vaccination during study treatment and within 3 months thereafter)., 13\) Any known hypersensitivity to any component of study treatment or other biologics, 14\) Malignancy or a history of malignancy except for fully treated skin basal cell or non\-metastatic squamous cell carcinomas; or cervical carcinoma in situ prior to the Screening visit., 15\) Planned major surgical procedure during the study., 16\) Participation in another research study involving an investigational product within 3 months prior to the Baseline (Day 1\) visit., 17\) Women who are pregnant or nursing., 2\) History of clinically significant abnormal laboratory values, as determined by the principal investigator, please refer to the Protocol for more information on the Exclusion criteria No.2\., 3\) Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit., 4\) Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB test., 5\) History of untreated or inadequately treated TB infection., 6\) Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening and Baseline (Day 1\) visit., 7\) Active unstable skin conditions in addition to AD that would interfere with the assessment of AD., 8\) Use of topical treatments for AD within 2 weeks before the Baseline (Day 1\) visit., 9\) Use of phototherapy for AD with ultraviolet (UV) A or UVB or regular use of a tanning booth within 4 weeks before the Baseline (Day 1\) visit.