TDM-180935 for Eczema

Recruiting at 12 trial locations

Overseen By Arthur P. Bertolino, MD, PhD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Technoderma Medicines Inc.

Must not be taking: PDE4 inhibitors, Corticosteroids, Immunomodulators, others

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Daniel J. Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Eligibility Criteria

This trial is for individuals with atopic dermatitis, also known as eczema. Specific details about who can join are not provided, but typically participants must have a confirmed diagnosis and meet certain health criteria.

Inclusion Criteria

I have signed a consent form for the trial.

I agree to use a simple moisturizer as instructed for the study period.

My kidney and liver functions are normal according to my recent tests.

Exclusion Criteria

Patient has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening

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 is currently enrolled in an investigational drug, biologic, or device study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into different groups and treated with TDM-180935 or placebo for 8 weeks

8 weeks

Visits at weeks 2, 4, 6, and 8

Pharmacokinetics

Eligible subjects in the PK cohort are treated with the high dose in an open label fashion

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TDM-180935

Trial Overview The study is testing TDM-180935 ointment in two different strengths (2.0% and 1.0%) against placebo ointments (vehicles) that look the same but don't contain the active drug. Participants will be randomly assigned to one of these groups.

Participant Groups

Group I: TDM-180935 topical ointment 2.0% Experimental Treatment 1 Intervention

Daily dose of 2.0% of TDM-180935 topical ointment

Group II: TDM-180935 topical ointment 1.0% Experimental Treatment 1 Intervention

Daily dose of 1.0% of TDM-180935 topical ointment

Group III: TDM-180935 topical vehicle ointment 1 Placebo Group 1 Intervention

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

Group IV: TDM-180935 topical vehicle ointment 2 Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Technoderma Medicines Inc.

Lead Sponsor

Trials

5

Recruited

220+

Therapeutics, Inc.

Industry Sponsor

Trials

31

Recruited

3,900+