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

NCT04836858 | Completed Phase 2 Results DMC

• 2 other identifiers: CCMK389B122012020-003406-31
• Study Type: interventional
• Target: 71
• Locations: 6 countries
• Sites: 18

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Safety; Efficacy; Atopic Eczema; Eczema; CMK389

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

Study Arms (4)

CMK389 10mg/kg i.v.

EXPERIMENTAL

Active

Biological: CMK389

Placebo i.v.

PLACEBO COMPARATOR

Placebo

Biological: Placebo

CMK389 300mg s.c.

EXPERIMENTAL

Active

Biological: CMK389

Placebo s.c.

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

CMK389 BIOLOGICAL

Active

CMK389 10mg/kg i.v.; CMK389 300mg s.c.

Placebo BIOLOGICAL

Placebo Comparator

Placebo i.v.; Placebo s.c.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Novartis Investigative Site

Pardubice, Czech Republic, 530 02, Czechia

Location

Novartis Investigative Site

Prague, 100 34, Czechia

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Bad Bentheim, 48455, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Budapest, 1085, Hungary

Location

Novartis Investigative Site

Szeged, 6720, Hungary

Location

Novartis Investigative Site

Gdansk, 80-546, Poland

Location

Novartis Investigative Site

Lodz, 90-265, Poland

Location

Novartis Investigative Site

Rzeszów, 35 055, Poland

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Related Links

• Patient Lay Trial Summary

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 8, 2021
• Study Start: April 20, 2021
• Primary Completion: July 14, 2022
• Study Completion: December 13, 2022
• Last Updated: June 20, 2024
• Results First Posted: May 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (1); FR (3); DE (7); CZ (2); HU (2); PL (3)