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

• ClinicalTrials.gov Identifier: NCT04836858
• Recruitment Status: Recruiting
• First Posted: April 8, 2021
• Last Update Posted: January 24, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Biological: CMK389; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 20, 2021
• Estimated Primary Completion Date: August 9, 2022
• Estimated Study Completion Date: November 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in Investigator Global assessment (IGA) response at Week 16 [ Time Frame: Week 16 ]
   To assess the efficacy of CMK389 in participants with moderate to severe AD

Secondary Outcome Measures :

1. Number of adverse events and serious adverse events [ Time Frame: Up to Week 32 (end of study) ]
   To assess the safety and tolerability of CMK389 in participants with AD

Eligibility Criteria

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

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 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.

Contacts and Locations

Contacts

Contact: Novartis Pharmaceuticals; +41613241111; novartis.email@novartis.com

Contact: Novartis Pharmaceuticals

Locations

Czechia

Novartis Investigative Site; Recruiting

Pardubice, Czech Republic, Czechia, 530 02

Novartis Investigative Site; Recruiting

Praha 10, Czechia, 100 34

France

Novartis Investigative Site; Recruiting

Lorient Cedex, France, 56322

Novartis Investigative Site; Recruiting

Marseille, France, 13008

Novartis Investigative Site; Recruiting

Nice Cedex, France, 06202

Novartis Investigative Site; Recruiting

Rouen, France, 76031

Germany

Novartis Investigative Site; Recruiting

Bad Bentheim, Germany, 48455

Novartis Investigative Site; Recruiting

Berlin, Germany, 10117

Novartis Investigative Site; Recruiting

Frankfurt, Germany, 60596

Novartis Investigative Site; Recruiting

Heidelberg, Germany, 69120

Novartis Investigative Site; Recruiting

Muenchen, Germany, 81377

Novartis Investigative Site; Recruiting

Muenster, Germany, 48149

Novartis Investigative Site; Recruiting

Osnabrueck, Germany, 49074

Novartis Investigative Site; Withdrawn

Ulm, Germany, 89081

Hungary

Novartis Investigative Site; Recruiting

Budapest, Hungary, 1085

Novartis Investigative Site; Recruiting

Pecs, Hungary, 7623

Novartis Investigative Site; Recruiting

Szeged, Hungary, 6720

Poland

Novartis Investigative Site; Recruiting

Gdansk, Poland, 80-546

Novartis Investigative Site; Recruiting

Lodz, Poland, 90-265

Novartis Investigative Site; Recruiting

Rzeszow, Poland, 35 055

Spain

Novartis Investigative Site; Recruiting

Cordoba, Andalucia, Spain, 14004

Novartis Investigative Site; Recruiting

Hospitalet de Llobregat, Barcelona, Spain, 08907

Novartis Investigative Site; Recruiting

Madrid, Spain, 28041

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04836858
• Other Study ID Numbers: CCMK389B12201; 2020-003406-31 ( EudraCT Number )
• First Posted: April 8, 2021
• Last Update Posted: January 24, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

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

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases