TDM-180935 for Eczema

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ointment, TDM-180935, to determine its effectiveness for people with eczema (atopic dermatitis). Eczema causes patches of skin to become inflamed, itchy, cracked, and rough. The trial includes different groups: some will use the TDM-180935 ointment, while others will use a placebo (a harmless substance resembling the ointment but without active ingredients) for comparison. Suitable participants have had mild to moderate eczema for at least two years, with symptoms affecting specific skin areas. Participants must apply the treatment daily and follow study instructions, including avoiding direct sunlight on treated areas. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in eczema care.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using certain medications before starting. You must not use topical products on the treatment area for 2 weeks and systemic treatments for eczema for 4 weeks before the trial. If you are in the PK Cohort, you must also stop using systemic prescription medications 14 days before and OTC medications 7 days before the trial.

Is there any evidence suggesting that TDM-180935 is likely to be safe for humans?

Research has shown that TDM-180935, a cream for eczema, was safe in earlier studies, meaning users did not experience major side effects. Current data suggests TDM-180935 is generally safe for humans. However, as testing continues, further research is necessary to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard eczema treatments, which typically include corticosteroids and topical calcineurin inhibitors, TDM-180935 offers a novel approach. This treatment is a topical ointment with a new active ingredient that targets eczema differently. Researchers are excited because it could offer an alternative for patients who don't respond well to current therapies. Moreover, the ointment comes in two strengths, providing flexibility in managing different severities of eczema. The potential for fewer side effects compared to steroids also adds to the excitement surrounding this investigational treatment.

What evidence suggests that TDM-180935 could be an effective treatment for eczema?

Research has shown that TDM-180935, a skin cream, yields promising results for treating atopic dermatitis, a common form of eczema. In an earlier study, 62.5% of patients using the 2% cream experienced significant improvement by week 8. This trial will test two concentrations of TDM-180935: a 1.0% ointment and a 2.0% ointment. The treatment works by blocking certain proteins that cause inflammation, reducing eczema flare-ups. The cream is also safe, with minimal absorption into the bloodstream. These findings suggest TDM-180935 could be an effective option for people with atopic dermatitis. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel J. Piacquadio, M.D.

Principal Investigator

Therapeutics Incorporated

Are You a Good Fit for This Trial?

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.

[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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06363461

NCT06363461 | Study of TDM-180935 in Atopic Dermatitis ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/technodermaiia-trial-atopic/

Technoderma begins dosing in atopic dermatitis therapy trial

The eight-week trial will assess the efficacy, safety, tolerability and pharmacokinetics of the TDM-180935 ointment. ... TDM-180935 is a small- ...

3.

healio.com

healio.com/news/dermatology/20250114/topical-jak-tyk-inhibitor-shows-efficacy-in-phase-2a-trial-for-atopic-dermatitis

Topical JAK, TYK inhibitor shows efficacy in phase 2a trial ...

62.5% of patients treated with TDM-180935 2% reached the primary endpoint by week 8. Technoderma Medicines has completed its phase 2a trial of ...

4.

prnewswire.com

prnewswire.com/news-releases/technoderma-medicines-completes-positive-ph2a-proof--of-concept-trial-with-topical-tdm-180935-ointment-for-atopic-dermatitis-302342710.html

Technoderma Medicines Completes Positive Ph2a Proof

Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis has now demonstrated a favorable safety profile and positive Proof-of-Concept in Ph2a ...

5.

biopharmaapac.com

biopharmaapac.com/news/31/5768/technoderma-medicines-announces-positive-phase-2a-results-for-tdm-180935-in-atopic-dermatitis.html

Technoderma Medicines Announces Positive Phase 2a ...

Topical JAK1/Tyk2 inhibitor shows strong efficacy, excellent tolerability, and minimal systemic absorption, paving the way for further clinical development in ...

6.

withpower.com

withpower.com/trial/phase-2-dermatitis-dermatitis-atopic-3-2024-585df

TDM-180935 for Eczema · Info for Participants

Prior Safety DataThis treatment has passed at least one previous human trial. What You Need to Know Before You Apply. What is the purpose of this trial ...

7.

pharmaceutical-technology.com

pharmaceutical-technology.com/data-insights/tdm-180935-technoderma-medicines-atopic-dermatitis-atopic-eczema-likelihood-of-approval-2/

TDM-180935 by Technoderma Medicines for Atopic ...

TDM-180935 is under clinical development by Technoderma Medicines and currently in Phase II for Atopic Dermatitis (Atopic Eczema).