Study of IMG-007 in Participants with Moderate to Severe Atopic Dermatitis

Korábbi kezelés

• 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.
• Use of biologic therapy including approved and investigational agents within 3 months or 5 half-lives, prior to the Baseline (Day 1) visit.
• 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).
• Planned major surgical procedure during the study.
• Participation in another research study involving an investigational product within 3 months prior to the Baseline (Day 1) visit.
• Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening and Baseline (Day 1) visit.
• Use of topical treatments for AD within 2 weeks before the Baseline (Day 1) visit.

Más betegség

• 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.
• Any known hypersensitivity to any component of study treatment or other biologics
• 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.
• Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit.
• Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB test.
• History of untreated or inadequately treated TB infection.
• Active unstable skin conditions in addition to AD that would interfere with the assessment of AD.

Laborértékek

• 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.

Egyéb

• Women who are pregnant or nursing.
• 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.

• Male or female aged ≥ 18 and < 75 years.
• Voluntarily signed informed consent to participate in the study
• Diagnosed with AD for ≥ 6 months according to the American Academy of Dermatology Consensus diagnostic criteria at the Screening visit.
• 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
• Documented history of inadequate response or lack of tolerability or for whom topical treatments are otherwise inadvisable.
• Agree to apply a stable dose of a non-medicated emollient (moisturizer).
• 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
• 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