A study to assess if CMK389 is effective, safe and tolerable in patients with moderate to severe Atopic Dermatitis (AD)

Phase 1

• Conditions: Moderate to Severe Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-003406-31-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-14
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified