Study of TDM-180935 in Atopic Dermatitis Patients

NCT06363461 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 239-13851-202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in m-EASI (modified Eczema Area and Severity Index) score

  Collection of EASI (Eczema Area and Severity Index) results at week 8. The total m-EASI score may range from zero (0) to a maximum of 64.8, and higher scores mean a worse outcome.

  8 weeks

Secondary Outcomes (7)

• Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score)

  8 weeks

• Change in m-EASI (modified Eczema Area and Severity Index) score

  6 weeks

• Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score

  8 weeks

• Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score

  8 weeks

• Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score

  8 weeks

Other Outcomes (8)

• Incidence (severity and causality) of any local and systemic AEs (adverse events)

  8 weeks

• Number of patients with presence (and severity) of the following LSRs (local skin reactions): skin pigmentation (hyperpigmentation and hypopigmentation), edema, erosion,scaling, and burning/stinging

  8 weeks

• Changes from Baseline in vital signs (temperature)

  8 weeks

Study Arms (4)

TDM-180935 topical ointment 1.0%

EXPERIMENTAL

Daily dose of 1.0% of TDM-180935 topical ointment

Drug: TDM-180935 topical ointment 1.0%

TDM-180935 topical ointment 2.0%

EXPERIMENTAL

Daily dose of 2.0% of TDM-180935 topical ointment

Drug: TDM-180935 topical ointment 2.0%

TDM-180935 topical vehicle ointment 1

PLACEBO COMPARATOR

Daily dose of placebo color matched to TDM-180935 topical ointment 1.0%

Drug: TDM-180935 topical vehicle ointment 1

TDM-180935 topical vehicle ointment 2

PLACEBO COMPARATOR

Daily dose of placebo color matched to TDM-180935 topical ointment 2.0%

Drug: TDM-180935 topical vehicle ointment 2

Interventions

TDM-180935 topical ointment 1.0% DRUG

TDM-180935 topical ointment 1.0%

TDM-180935 topical ointment 1.0%

TDM-180935 topical ointment 2.0% DRUG

TDM-180935 topical ointment 2.0%

TDM-180935 topical ointment 2.0%

TDM-180935 topical vehicle ointment 1 DRUG

TDM-180935 topical vehicle ointment 1

TDM-180935 topical vehicle ointment 1

TDM-180935 topical vehicle ointment 2 DRUG

TDM-180935 topical vehicle ointment 2

TDM-180935 topical vehicle ointment 2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 1. Patient is a male ≥ 18 years old 2. Patient is a post-menopausal or surgically sterile female ≥ 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A) Patient is a male ≥ 18 years old at Visit 1/Screening. B) Patient is a post-menopausal or surgically sterile female ≥ 18 years old at Visit 1/Screening.
• Patient has provided written informed consent.
• Male patients who are sexually active with a female partner and are not surgically sterile must use a highly effective method of birth control as described in the informed consent form. Note: Male patients must refrain from sperm donation for at least 90 days after application of their last dose of IP (investigational product).
• Patient has active mild or moderate AD with a modified-Eczema Area and Severity Index (m-EASI) score of 5-16 and a history of AD duration ≥ 2 years.
• Patient has an AD body surface area (BSA) between 3 and 12% in the area to be treated (excluding head/neck, hands/feet, genitalia, and intertriginous areas) at Baseline.
• Patient is willing and able to apply the IP(s) as directed, comply with study instructions (including avoiding direct sunlight exposure to the areas of IP application), and commit to all follow-up visits for the duration of the study. Note: The use of topical sunscreen is permitted provided the patient has used the sunscreen previously and it does not contain any prohibited medications/ingredients.
• Patient, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation or exposes the patient to an unacceptable risk by study participation.
• Patient agrees to apply a bland moisturizer as directed for the duration of the study.
• Patient has normal renal and hepatic function as determined by the Visit 1/Screening laboratory results in the opinion of the investigator.
• \[For PK Cohort Only\] Patient is a non-smoker, defined as not having smoked or used any form of tobacco or non-tobacco products containing nicotine in more than 6 months before Visit 2/Baseline.
• \[For PK Cohort Only\] Patient has a body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg at Visit 1/Screening.

You may not qualify if:

• Patient has any dermatological disorders of the skin within 20 cm of the areas to be treated with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, psoriasis, folliculitis, notable scarring (linear scar \> 2.5 cm, etc.), or skin atrophy at Visit 2/Baseline.
• Patient has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy at Visit 2/Baseline.
• Patient has any visible inflammatory skin disease, injury, or condition of their skin that could compromise patient safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
• Patient has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• Patient has any condition, which, in the investigator's opinion, would make it unsafe for the patient to participate in this study, including clinically significant abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of the IP.
• Patient has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
• Patient is currently enrolled in an investigational drug, biologic, or device study.
• Patient has used an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit 2/Baseline.
• Patient has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
• Patient has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
• Patient has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline. Note: Patients with a positive drug screen believed by the investigator to be the result of medically appropriate prescription medication use can be enrolled with Medical Monitor approval.
• Patient has used topical cosmetic (excluding bland moisturizers), herbal, over-the- counter (OTC) or prescription products within areas to be treated within 2 weeks prior to dosing at Visit 2/Baseline.
• Patient has used systemic prescription treatment for AD or that in the opinion of the investigator may affect the patient's AD (examples include, but are not limited to PDE4 (Phosphodiesterase-4) inhibitors, corticosteroids, immunomodulators, antimetabolites, antibiotics, retinoids, etc.) within 4 weeks prior to Visit 2/Baseline. Note: systemic corticosteroids do not include intranasal, inhaled, or ophthalmic corticosteroids for the management of allergies, pulmonary disorders, or other conditions.
• Patient has used systemic biologic therapy (i.e., dupilumab) for AD or that in the opinion of the investigator may affect the patient's AD within 5 half-lives of the biologic therapy prior to Visit 2/Baseline.
• Patient has been diagnosed with COVID-19 (Coronavirus Disease of 2019) within 4 weeks of Visit 1/Screening.

Sponsors & Collaborators

• Technoderma Medicines Inc.: lead
• Therapeutics, Inc.: collaborator

Study Sites (7)

Site 5

Rolling Meadows, Illinois, 60008, United States

Location

Site 8

Covington, Louisiana, 70433, United States

Location

Site 4

New Brighton, Minnesota, 55112, United States

Location

Site 7

Anderson, South Carolina, 29621, United States

Location

Site 3

Austin, Texas, 78759, United States

Location

Site 1

College Station, Texas, 77845, United States

Location

Site 2

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Study Officials

• Daniel J. Piacquadio, M.D.

  Therapeutics Incorporated

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 12, 2024
• Study Start: April 13, 2024
• Primary Completion: March 8, 2025
• Study Completion: April 8, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (7)