Moderate to Severe Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult male or female participants with chronic atopic dermatitis, according to the American Academy of Dermatology Consensus Criteria (Eichenfield et al 2014), aged 18 to 65 years, present for at least 1 year before screening. - Moderate to severe AD defined as: --IGA score of = 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline (or Screening if Baseline is omitted) --EASI score of = 12 at Baseline (or Screening if Baseline is omitted) --Pruritus (NRS) of at least = 3 at Baseline (or Screening if Baseline is omittied) - Participants who are candidates for a systemic therapy, defined as e.g. inadequate response to treatment with topical medications, or from whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks, patients with large affected body surface areas), as assessed by the investigator - Participants must have a body mass index (BMI) at screening within the range of 18 to =35 kg/m2. Other criteria may apply as per protocol, Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity (e.g., Netherton Syndrome, or other ichthyoses, cutaneous T-Cell Lymphoma, extensive contact dermatitis, chronic actinic dermatitis and other forms of eczema, such as seborrheic and microbial eczema). - Participants taking prohibited medication with their wash out period - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations. - Any active, recent or recurrent systemic or localized infection at screening or prior to first treatment which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for immunomodulatory therapy. - Any other current or past clinical significant medical condition, including psychiatric condition, which in the investigator's opinion may interfere with safety of participants, study objectives or adherence to the protocol. - Participants with confirmed abnormal absolute neutrophil count (ANC) of <1.5 x 109/L or with thrombocytopenia of < 75.0 x 109/L at screening and baseline (unless baseline visit is omitted) - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases - History of hypersensitivity to any component of the study drug product, or to drugs of similar chemical classes (i.e., IgG-1 related biologic agents) - History of severe or serious allergy or hypersensitivity reactions, such as anaphylactic shock, asthma, or uncontrolled urticaria. - Women of child-bearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after last dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of CMK389 in participants with moderate to severe AD;Secondary Objective: To assess the safety and tolerability of CMK389 in participants with AD;Primary end point(s): IGA response (defined as clear or almost clear and at least 2 point reduction from baseline) ;Timepoint(s) of evaluation of this end point: At week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number, seriousness and frequency of Adverse events over time;Timepoint(s) of evaluation of this end point: From Baseline to EoS. | — |
Countries
France, Germany, Hungary, Poland
Contacts
Public ContactPublic Information Desk
Novartis Hungary Kft.
Outcome results
None listed