Clinical trial NCT04836858: A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Safety
Efficacy
Atopic Eczema
Eczema
CMK389
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This was a randomized, placebo-controlled, parallel-group, non-confirmatory, investigator and participant blinded study in adult participants with moderate to severe AD. The study consisted of up to 4 weeks screening period to assess participants eligibility, the baseline visit, 4-weekly administrations of CMK389 within the first 12 weeks of the 16-week treatment period, and an approximately 12 weeks follow up period which finished with the end of study visit (EoS). In addition, for women of child-bearing potential, pregnancy tests were done for 6 months after the last dose of CMK389.

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 enrolment, or within 5 half-lives of enrolment, 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, such as:

  * Any acute bacterial, fungal, or viral skin/mucosal infection that has not resolved within 2 weeks prior to first treatment or within 12 months in case of eczema herpeticum.
  * Clinically infected AD within 4 weeks prior to first treatment.
  * Any other infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to first treatment.
  * Tuberculosis (TB), Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis 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 10\^9/L or with thrombocytopenia of \< 75.0 x 10\^9/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.

Primary outcomes:
measure: Number of Participants With Investigator Global Assessment (IGA) Response
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Other outcomes:
Locations:
city: Pardubice
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Praha 10
country: Czechia
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Rouen
country: France
facility: Novartis Investigative Site
city: Bad Bentheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Rzeszow
country: Poland
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
Study officials:
References: