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 was 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

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• 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, 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 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.

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 10mg/kg i.v.; Active	Biological: CMK389; Active
Placebo Comparator: Placebo i.v.; Placebo	Biological: Placebo; Placebo Comparator
Experimental: CMK389 300mg s.c.; Active	Biological: CMK389; Active
Placebo Comparator: Placebo s.c.; Placebo	Biological: Placebo; Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Investigator Global Assessment (IGA) Response	The Investigator Global assessment (IGA) scale used was vIGA-AD^TM (Validated Investigator Global Assessment scale for Atopic Dermatitis). The IGA rating scale was used to determine the severity of atopic dermatitis and clinical response to treatment. It reflected a participant's overall disease severity for the whole body based on a 5-point scale. The 5-point scale included: clear, almost clear, mild, moderate, and severe disease. IGA response is defined as clear or almost clear and at least a 2 point-reduction from baseline at week 16.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.	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.

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Patient Lay Trial Summary

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): July 14, 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): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

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