Atopic DermatitisPhase 2NCT06363461

Study of TDM-180935 in Atopic Dermatitis Patients

A Phase 2 study testing TDM-180935 topical ointment 1.0% and TDM-180935 topical ointment 2.0% in people with Atopic Dermatitis, run by Technoderma Medicines Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: TDM-180935 topical ointment 1.0% and TDM-180935 topical ointment 2.0%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 7 sitesUnited States
Study dates: 13 Apr 2024to 8 Apr 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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 known or suspected malignancy at Visit 2/Baseline excluding basal cell skin cancer unless it is associated with the area to be treated per Exclusion Criterion no. 1.
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.

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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.
Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Patient has previously been treated with the IP.
Patient has a history of sensitivity to any of the ingredients in the IP.
Patient has ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the investigator's opinion, should exclude participation in the study.
[For PK Cohort Only] Patient has a donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to Visit 2/Baseline.
[For PK Cohort Only] Patient has used systemic prescription medications, herbal (including St John's Wort, herbal teas and garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline.
[For PK Cohort Only] Patient has used systemic OTC medications or vitamins within 7 days prior to dosing at Visit 2/Baseline. (Note: Use of acetaminophen at < 3g/day is permitted).
[For PK Cohort Only] Patient received a live or live attenuated vaccine within 4 weeks of dosing at Visit 2/Baseline.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Site 7
Anderson, South Carolina, 29621
Site 3
Austin, Texas, 78759
Site 1
College Station, Texas, 77845
Site 8
Covington, Louisiana, 70433
Site 4
New Brighton, Minnesota, 55112
Site 2
Norfolk, Virginia, 23502
Site 5
Rolling Meadows, Illinois, 60008

Other trials in United States

About this study

Official title: A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients

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

Read the detailed description

Protocol 239-13851-202 is a Phase 2a study entitled "A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients". Eligible subjects (24) in the randomized portion of the study will be randomized (2:2:1:1) to 1 of the 4 groups (low dose vs high dose vs placebo 1 vs placebo 2) and treated for 8 weeks. Eligible subjects (6) in the PK (pharmacokinetics) cohort will be treated with the high dose in an open label fashion.

Conditions: Atopic Dermatitis
Being tested: TDM-180935 topical ointment 1.0%, TDM-180935 topical ointment 2.0%, TDM-180935 topical vehicle ointment 1, TDM-180935 topical vehicle ointment 2
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDM-180935 topical ointment 1.0%Drug
TDM-180935 topical ointment 1.0%
TDM-180935 topical ointment 2.0%Drug
TDM-180935 topical ointment 2.0%
TDM-180935 topical vehicle ointment 1Drug
TDM-180935 topical vehicle ointment 1
TDM-180935 topical vehicle ointment 2Drug
TDM-180935 topical vehicle ointment 2

Study groups in NCT06363461
Study group	Role	What they receive
TDM-180935 topical ointment 1.0%	Experimental	Daily dose of 1.0% of TDM-180935 topical ointment Receives: Drug: TDM-180935 topical ointment 1.0%
TDM-180935 topical ointment 2.0%	Experimental	Daily dose of 2.0% of TDM-180935 topical ointment Receives: 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% Receives: 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% Receives: Drug: TDM-180935 topical vehicle ointment 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Collection of vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score) at week 8. The vIGA-AD is a static morphological 5-point ordinal scale from 0 (clear) to 4 (severe).
Measured: 8 weeks
Change in m-EASI (modified Eczema Area and Severity Index) score
Collection of EASI (Eczema Area and Severity Index) results at weeks 2, 4, and 6. The total m-EASI score may range from zero (0) to a maximum of 64.8, and higher scores mean a worse outcome.
Measured: 6 weeks
Proportion of patients with a 50% improvement 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.
Measured: 8 weeks
Proportion of patients with a 75% improvement 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.
Measured: 8 weeks
Proportion of patients with a 90% improvement 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.
Measured: 8 weeks
Change in BSA (body surface area) affected
Collection of BSA affected at weeks 2, 4, 6, and 8
Measured: 8 weeks
Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score
Collection of WI-NRS (Worst Itch-Numeric Rating Scale) score at week 8. The level of itching is described on an 11-point scale anchored at 0, representing "no itch" and 10, representing, "worst itch imaginable".
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 20248 Apr 2025

First posted12 Apr 2024
Study start13 Apr 2024
Primary completion8 Mar 2025
Study completion8 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06363461
Sponsor's protocol ID: 239-13851-202
Status last verified: Apr 2025
First submitted: 3 Apr 2024
Last updated: 24 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients
ClinicalTrials.gov ID: NCT06363461
Acronym / sponsor ID: 239-13851-202
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Technoderma Medicines Inc.Industry (pharma, biotech, devices)
Collaborators: Therapeutics, Inc.
Study start: 13 Apr 2024 (actual)
Primary completion: 8 Mar 2025 (actual)
Study completion: 8 Apr 2025 (actual)
First posted: 12 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TDM-180935 topical ointment 1.0%	Experimental	Drug: TDM-180935 topical ointment 1.0%Daily dose of 1.0% of TDM-180935 topical ointment
TDM-180935 topical ointment 2.0%	Experimental	Drug: TDM-180935 topical ointment 2.0%Daily dose of 2.0% of TDM-180935 topical ointment
TDM-180935 topical vehicle ointment 1	Placebo comparator	Drug: TDM-180935 topical vehicle ointment 1Daily dose of placebo color matched to TDM-180935 topical ointment 1.0%
TDM-180935 topical vehicle ointment 2	Placebo comparator	Drug: TDM-180935 topical vehicle ointment 2Daily dose of placebo color matched to TDM-180935 topical ointment 2.0%

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (24 listed)

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 known or suspected malignancy at Visit 2/Baseline excluding basal cell skin cancer unless it is associated with the area to be treated per Exclusion Criterion no. 1.
Patient has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TDM-180935 topical ointment 1.0%TDM-180935 topical ointment 1.0%	Drug	TDM-180935 topical ointment 1.0%
TDM-180935 topical ointment 2.0%TDM-180935 topical ointment 2.0%	Drug	TDM-180935 topical ointment 2.0%
TDM-180935 topical vehicle ointment 1TDM-180935 topical vehicle ointment 1	Drug	TDM-180935 topical vehicle ointment 1
TDM-180935 topical vehicle ointment 2TDM-180935 topical vehicle ointment 2	Drug	TDM-180935 topical vehicle ointment 2

Primary outcome

Change in m-EASI (modified Eczema Area and Severity Index) score
Time frame: 8 weeks
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.

7 secondary outcomes

Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score)
Time frame: 8 weeks
Change in m-EASI (modified Eczema Area and Severity Index) score
Time frame: 6 weeks
Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score
Time frame: 8 weeks
Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score
Time frame: 8 weeks
Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score
Time frame: 8 weeks
Change in BSA (body surface area) affected
Time frame: 8 weeks
Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J. Piacquadio, M.D. study director

Therapeutics Incorporated

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TDM-180935 topical ointment 1.0% and TDM-180935 topical ointment 2.0% in people with Atopic Dermatitis, run by Technoderma Medicines Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in m-EASI (modified Eczema Area and Severity Index) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06363461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.