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

NCT ID: NCT04836858

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-12-13

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CMK389 10mg/kg i.v.

Active

Group Type: EXPERIMENTAL

CMK389

Intervention Type: BIOLOGICAL

Active

Placebo i.v.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo Comparator

CMK389 300mg s.c.

Active

Group Type: EXPERIMENTAL

CMK389

Intervention Type: BIOLOGICAL

Active

Placebo s.c.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo Comparator

Interventions

CMK389

Active

Intervention Type: BIOLOGICAL

Placebo

Placebo Comparator

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Pardubice, Czech Republic, Czechia

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Marseille, , France

Novartis Investigative Site

Nice, , France

Novartis Investigative Site

Rouen, , France

Novartis Investigative Site

Bad Bentheim, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Frankfurt, , Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

München, , Germany

Novartis Investigative Site

Münster, , Germany

Novartis Investigative Site

Osnabrück, , Germany

Novartis Investigative Site

Budapest, , Hungary

Novartis Investigative Site

Szeged, , Hungary

Novartis Investigative Site

Gdansk, , Poland

Novartis Investigative Site

Lodz, , Poland

Novartis Investigative Site

Rzeszów, , Poland

Novartis Investigative Site

Córdoba, Andalusia, Spain

Countries

Czechia; France; Germany; Hungary; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1800

Patient Lay Trial Summary

Other Identifiers

2020-003406-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCMK389B12201

Identifier Type: -

Identifier Source: org_study_id