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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Biological: Placebo; Biological: CMK389

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Praha 10, Czechia, 100 34
    • Novartis Investigative Site
  • Czech Republic
    • Pardubice, Czech Republic, Czechia, 530 02
      • Novartis Investigative Site
• France
  • Marseille, France, 13008
    • Novartis Investigative Site
  • Nice Cedex, France, 06202
    • Novartis Investigative Site
  • Rouen, France, 76031
    • Novartis Investigative Site
• Germany
  • Bad Bentheim, Germany, 48455
    • Novartis Investigative Site
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Frankfurt, Germany, 60596
    • Novartis Investigative Site
  • Heidelberg, Germany, 69120
    • Novartis Investigative Site
  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Osnabrueck, Germany, 49074
    • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1085
    • Novartis Investigative Site
  • Szeged, Hungary, 6720
    • Novartis Investigative Site
• Poland
  • Gdansk, Poland, 80-546
    • Novartis Investigative Site
  • Lodz, Poland, 90-265
    • Novartis Investigative Site
  • Rzeszow, Poland, 35 055
    • Novartis Investigative Site
• Spain
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMK389 high dose; Active	Biological: CMK389; Active
Placebo Comparator: Placebo high dose; Placebo	Biological: Placebo; Placebo Comparator
Experimental: CMK389 low dose; Active	Biological: CMK389; Active
Placebo Comparator: Placebo low dose; Placebo	Biological: Placebo; Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Investigator Global assessment (IGA) response at Week 16	To assess the efficacy of CMK389 in participants with moderate to severe AD	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events and serious adverse events	To assess the safety and tolerability of CMK389 in participants with AD	Up to Week 32 (end of study)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Atopic Dermatitis; Eczema; Atopic Eczema; CMK389
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: CCMK389B12201; 2020-003406-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No