Atopic DermatitisPhase 2NCT07167758
A Study Evaluating TRIV-509 in Atopic Dermatitis
A Phase 2 study testing TRIV-509 in people with Atopic Dermatitis, run by Triveni Bio at 32 sites in 7 countries.
Trial summary
The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509. Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and… 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-509
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 32 sitesin 7 countries
- Study dates
- 26 Aug 2025to Jun 2027
- 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 AD
Who cannot join
- Severe or uncontrolled medical conditions.
- Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
United States9 sites
Triveni Bio Site #16
Bellaire, Texas, 77401
Triveni Bio Site #1
Camp Hill, Pennsylvania, 17011
Triveni Bio Site #5
Dallas, Texas, 75230
Triveni Bio Site #11
Fountain Valley, California, 17271
Triveni Bio Site #6
Indianapolis, Indiana, 46250
Triveni Bio Site #3
Miami, Florida, 33016
Triveni Bio Site #4
San Diego, California, 92123
Triveni Bio Site #10
South Bend, Indiana, 46617
Triveni Bio Site #8
Spokane, Washington, 99202
Poland8 sites
Triveni Bio Site #24
Chorzów, Silesian Voivodeship, 41-500
Triveni Bio Site #25
Katowice, Silesian Voivodeship, 4-600
Triveni Bio Site #27
Katowice, Silesian Voivodeship, 40-611
Triveni Bio Site #30
Poznan, Wielkopolska, 60-309
Triveni Bio Site #26
Poznan, Wielkopolska, 61-731
Triveni Bio Site #29
Sosnowiec, 41-200
Triveni Bio Site #28
Warsaw, Masovian Voivodeship, 00-872
Triveni Bio Site #33
Wroclaw, Lower Silesian Voivodeship, 51-604
Czechia5 sites
Triveni Bio Site #22
Ostrava, 70200
Triveni Bio Site #31
Pardubice, 530 02
Triveni Bio Site #21
Prague, 11000
Triveni Bio Site #37
Prague, 13000
Triveni Bio Site #23
Prague, 15000
Canada4 sites
Triveni Bio Site #13
Ajax, Ontario, L1S 7K8
Triveni Bio Site #17
Newmarket, Ontario, L3Y 5G8
Triveni Bio Site #12
Niagara Falls, Ontario, L2H 1H5
Triveni Bio Site #15
North York, Ontario, M2N 3A6
Hungary3 sites
Triveni Bio Site #41
Budapest, 1033
Triveni Bio Site #34
Budapest, 1066
Triveni Bio Site #43
Debrecen, 4032
Bulgaria2 sites
Triveni Bio Site #38
Pleven, 5800
Triveni Bio Site #39
Sofia, 1172
About this study
Official title: A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis
The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
- Conditions
- Atopic Dermatitis
- Being tested
- TRIV-509, 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-509Drug
TRIV-509 (Subcutaneous injection)
PlaceboDrug
Drug: Placebo (Matching Placebo subcutaneous injection)
| Study group | Role | What they receive |
|---|---|---|
| First TRIV-509 then Placebo | Experimental | Not described Receives: Drug: TRIV-509; Drug: Placebo |
| First Placebo then TRIV-509 | Experimental | Not described Receives: Drug: TRIV-509; 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 at Week 16
Measured: Baseline to Week 16
Secondary outcomes (5)
Percentage of participants with improvement of AD at Week 16
Measured: Baseline through Week 16
Percentage of participants with TEAEs.
Measured: For 16 Weeks
Percentage of participants with SAEs.
Measured: For 16 Weeks
Percentage of participants with anti-TRIV-509 antibodies
Measured: For 16 Weeks
Serum concentration of TRIV-509
Measured: For 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start26 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionJun 2027 (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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triveni Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167758
- Sponsor's protocol ID
- 509-101
- Status last verified
- Apr 2026
- First submitted
- 19 Aug 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07167758
- Acronym / sponsor ID
- 509-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Triveni BioIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Sep 2025 (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-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First TRIV-509 then Placebo | Experimental | Drug: TRIV-509, Drug: Placebo |
| First Placebo then TRIV-509 | Experimental | Drug: TRIV-509, 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 AD
Key exclusion criteria (2 listed)
- Severe or uncontrolled medical conditions.
- Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, 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-509TRIV-509 (Subcutaneous injection) | Drug | First Placebo then TRIV-509, First TRIV-509 then Placebo |
| PlaceboDrug: Placebo (Matching Placebo subcutaneous injection) | Drug | First Placebo then TRIV-509, First TRIV-509 then Placebo |
Primary outcome
Percentage of participants with improvement of AD at Week 16
Time frame: Baseline to Week 16
5 secondary outcomes
Percentage of participants with improvement of AD at Week 16
Time frame: Baseline through Week 16
Percentage of participants with TEAEs.
Time frame: For 16 Weeks
Percentage of participants with SAEs.
Time frame: For 16 Weeks
Percentage of participants with anti-TRIV-509 antibodies
Time frame: For 16 Weeks
Serum concentration of TRIV-509
Time frame: For 16 Weeks
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 27 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRIV-509 in people with Atopic Dermatitis, run by Triveni Bio at 32 sites in 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Poland, Czechia, Canada, Hungary and 2 more countries. 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. 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?
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?
Percentage of participants with improvement of AD at Week 16 (time frame: Baseline to 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 27 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.