Atopic DermatitisPhase 2NCT04753034
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
A Phase 2 study testing TER-101 in people with Atopic Dermatitis, run by Teres Bio, Inc. at 12 sites in United States.
Trial summary
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TER-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Jan 2021to 3 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescent or adult subject aged 12 - 65 years.
- Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA
Who cannot join
- AD with known hypersensitivity to excipients of TER-101 Ointment
- Subjects who are immunocompromised
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Teres Bio Site 02
Clarksville, Indiana, 47129
Teres Bio Site 03
College Station, Texas, 77845
Teres Bio Site 04
Encinitas, California, 92024
Teres Bio Site 08
High Point, North Carolina, 27262
Teres Bio Site 01
Louisville, Kentucky, 40241
Teres Bio Site 12
North Miami Beach, Florida, 33162
Teres Bio Site 06
Pflugerville, Texas, 78660
Teres Bio site 09
Saint Joseph, Missouri, 64506
Teres Bio Site 07
San Antonio, Texas, 78229
Teres Bio site 05
Scottsdale, Arizona, 85255
Teres Bio Site 10
Tampa, Florida, 33613
Teres Bio Site 11
Wilmington, North Carolina, 28405
About this study
Official title: A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- TER-101, Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TER-101Drug
Active Comparator
VehicleDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| TER-101 | Experimental | BID (twice daily) application Receives: Drug: TER-101 |
| Vehicle | Placebo comparator | Vehicle ointment, BID (twice daily) application Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in EASI From Baseline at Day 29
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
Measured: 29 days
Secondary outcomes (4)
Changes in EASI Over Time
EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Measured: 15 days
Change in IGA From Baseline Over Time
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
- = Almost Clear
- = Mild
- = Moderate
- = Severe
Measured: 29 Days
Changes in Itch Over Time
The WI-NRS asks subjects to report their worst itch (maximal intensity) during the last 24 hours on an 11-point NRS, ranging from 0 = "no itch at all" to 10 = "worst itch you can imagine".
Measured: 29 days
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Sum of erythema, itch, and burning at the time of visit compared to baseline measured on a 0 - 3 scale for each component. A score of 0 indicates no erythema, itch or burning. Higher scores indicate worsening tolerability: 1 (mild), 2 (moderate), 3 (severe)
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start18 Jan 2021
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teres Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753034
- Sponsor's protocol ID
- TER101-AD-201
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
- ClinicalTrials.gov ID
- NCT04753034
- Acronym / sponsor ID
- TER101-AD-201
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Teres Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TER-101 | Experimental | Drug: TER-101BID (twice daily) application |
| Vehicle | Placebo comparator | Drug: VehicleVehicle ointment, BID (twice daily) application |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adolescent or adult subject aged 12 - 65 years.
- Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA
Key exclusion criteria (2 listed)
- AD with known hypersensitivity to excipients of TER-101 Ointment
- Subjects who are immunocompromised
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 |
|---|---|---|
| TER-101Active Comparator | Drug | TER-101 |
| VehiclePlacebo Comparator | Drug | Vehicle |
Primary outcome
Percent Change in EASI From Baseline at Day 29
Time frame: 29 days
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
4 secondary outcomes
Changes in EASI Over Time
Time frame: 15 days
Change in IGA From Baseline Over Time
Time frame: 29 Days
Changes in Itch Over Time
Time frame: 29 days
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Time frame: 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 TER-101 in people with Atopic Dermatitis, run by Teres Bio, Inc. at 12 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 2 inclusion and 2 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in EASI From Baseline at Day 29 (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.