A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis.

  • STATUS
    Recruiting
  • End date
    Oct 6, 2022
  • participants needed
    64
  • sponsor
    Novartis Pharmaceuticals
Updated on 1 July 2022
body mass index
topical agents

Summary

The main purpose of this phase 2 study is to assess the efficacy and safety of CMK389 in patients with atopic dermatitis.

Details
Condition Atopic Dermatitis
Treatment Placebo, CMK389
Clinical Study IdentifierNCT04836858
SponsorNovartis Pharmaceuticals
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult male or female participants with chronic atopic dermatitis, aged 18 to 65 years, present for at least 1 year before screening
Participants with Moderate to severe AD defined by IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline, EASI score of ≥ 12 at Baseline and Pruritus (NRS) of at least ≥ 3 at Baseline
Participants who are candidates for a systemic therapy, defined as e.g. inadequate response to treatment with topical medications, or for 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

Exclusion Criteria

Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity
Participants taking prohibited medication not completing the 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, that has not resolved within 2 weeks prior to first treatment or within 12 months in case of ezcema herpeticum, Clinically infected AD within 4 weeks prior to first treatment, TB, HIV, Hepatitis B and C
Any other current or past clinically significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of the participant, 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
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
History of severe or serious allergy or hypersensitivity reactions, such as anaphylactic shock, asthma, or uncontrolled urticaria
Pregnant or nursing (lactating) women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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