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

A Randomized, Subject and Investigator Blinded, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis

ClinicalTrials.gov Identifier: NCT04836858

Novartis Reference Number: CCMK389B12201

Last Update: Nov 10, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Atopic Dermatitis
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
64 participants
Start date 
Apr 20, 2021
Completion date 
Oct 20, 2022
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Biological
CMK389
Active
Biological
Placebo
Placebo Comparator

Eligibility Criteria

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.

Study Locations

Czech Republic
Novartis Investigative Site
Recruiting
Pardubice, 530 02
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Praha 10, 100 34
-
Czech Republic
Germany
Novartis Investigative Site
Recruiting
Bad Bentheim, 48455
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60596
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Osnabrueck, 49074
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1085
-
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7623
-
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80-546
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-265
-
Poland
Novartis Investigative Site
Recruiting
Rzeszow, 35 055
-
Poland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]