Atopic DermatitisPhase 2NCT07782333
A Study Evaluating TRIV-573 in Atopic Dermatitis
A Phase 2 study testing TRIV-573 in people with Atopic Dermatitis, run by Triveni Bio at 17 sites in 3 countries.
Trial summary
The goal of this interventional study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-573. Participants will receive 5 doses of the study intervention that they are randomized to (TRIV-573 or placebo). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TRIV-573
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 9 Sep 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has Atopic Dermatitis.
- Has moderate to severe, active and symptomatic atopic dermatitis.
Who cannot join
- Severe or uncontrolled medical conditions.
- Use of prohibited medications within stated washout periods.
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
United States13 sites, 13 recruiting
- Recruiting
Triveni Bio Site #13
Bay City, Michigan, 48706
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #16
Boardman, Ohio, 44512
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #11
Boca Raton, Florida, 33486
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #1
Camp Hill, Pennsylvania, 17011
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #15
Fountain Valley, California, 92708
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #2
Indianapolis, Indiana, 46250
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #4
Los Angeles, California, 90045
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #7
Miami, Florida, 33126
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #3
Miami, Florida, 33142
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #14
Myrtle Beach, South Carolina, 29588
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #9
San Antonio, Texas, 78213
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #6
San Antonio, Texas, 78218
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #8
Spokane, Washington, 99202
Study Director, 781-472-2230, clinicaltrials@triveni.bio
Canada2 sites, 2 recruiting
- Recruiting
Triveni Bio Site #5
Barrie, Ontario, L4M7G1
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #17
Calgary, Alberta, T2W4X9
Study Director, 781-472-2230, clinicaltrials@triveni.bio
Ukraine2 sites, 2 recruiting
- Recruiting
Triveni Bio Site #12
Ivano-Frankivsk, 76000
Study Director, 781-472-2230, clinicaltrials@triveni.bio
- Recruiting
Triveni Bio Site #10
Kyiv, 02000
Study Director, 781-472-2230, clinicaltrials@triveni.bio
About this study
Official title: A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-573 in Participants With Moderate to Severe Atopic Dermatitis
The goal of this interventional study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-573.
Participants will receive 5 doses of the study intervention that they are randomized to (TRIV-573 or placebo).
The study duration for individual participants is up to 40 weeks, including a Screening period of up to 30 days.
- Conditions
- Atopic Dermatitis
- Being tested
- TRIV-573, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIV-573Drug
TRIV-573 (Subcutaneous injection)
PlaceboDrug
Placebo (Matching Placebo subcutaneous injection)
| Study group | Role | What they receive |
|---|---|---|
| TRIV-573 | Experimental | Not described Receives: Drug: TRIV-573 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with improvement of AD
Measured: Baseline through Week 16
Secondary outcomes (4)
Percentage of participants with improvement of AD
Measured: Baseline through Week 16
Percentage of participants with TEAEs
Measured: Baseline through Week 36
Serum concentration of TRIV-573
Measured: Baseline through Week 36
Percentage of participants with anti-TRIV-573 antibodies
Measured: Baseline through Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start9 Sep 2026
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Triveni Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782333
- Sponsor's protocol ID
- 573-101
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-573 in Participants With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07782333
- Acronym / sponsor ID
- 573-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Triveni BioIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
The goal of this interventional study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-573.
Participants will receive 5 doses of the study intervention that they are randomized to (TRIV-573 or placebo).
The study duration for individual participants is up to 40 weeks, including a Screening period of up to 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRIV-573 | Experimental | Drug: TRIV-573 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has Atopic Dermatitis.
- Has moderate to severe, active and symptomatic atopic dermatitis.
Key exclusion criteria (2 listed)
- Severe or uncontrolled medical conditions.
- Use of prohibited medications within stated washout periods.
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 |
|---|---|---|
| TRIV-573TRIV-573 (Subcutaneous injection) | Drug | TRIV-573 |
| PlaceboPlacebo (Matching Placebo subcutaneous injection) | Drug | Placebo |
Primary outcome
Percentage of participants with improvement of AD
Time frame: Baseline through Week 16
4 secondary outcomes
Percentage of participants with improvement of AD
Time frame: Baseline through Week 16
Percentage of participants with TEAEs
Time frame: Baseline through Week 36
Serum concentration of TRIV-573
Time frame: Baseline through Week 36
Percentage of participants with anti-TRIV-573 antibodies
Time frame: Baseline through Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRIV-573 in people with Atopic Dermatitis, run by Triveni Bio at 17 sites in 3 countries.
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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Ukraine. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Triveni Bio, Inc (+1 (781) 472-2230, clinicaltrials@triveni.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with improvement of AD (time frame: Baseline through Week 16). 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 28 Oct 2026.