TRIV-509 for Atopic Dermatitis

Recruiting at 30 trial locations

Overseen By Study Director Triveni Bio, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Triveni Bio

Must not be taking: Topical treatments, Immunosuppressives

Disqualifiers: Severe conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TRIV-509, an experimental therapy for individuals with moderate to severe atopic dermatitis, a chronic condition causing itchy and inflamed skin. The trial aims to determine if TRIV-509 effectively treats symptoms and assesses its safety. Participants will initially receive either TRIV-509 or a placebo and then switch to the other option. Individuals with active symptoms of moderate to severe atopic dermatitis who are not using certain treatments may qualify for this trial. As a Phase 2 trial, this research measures TRIV-509's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in treatment.

Do I need to stop my current medications for the trial?

The trial requires stopping certain medications like topical treatments, phototherapy, and immunosuppressive or immunomodulatory therapies before participating. The exact time without these medications (washout period) is specified in the trial details.

Is there any evidence suggesting that TRIV-509 is likely to be safe for humans?

Research shows that TRIV-509 may help treat atopic dermatitis by strengthening the skin's barrier and reducing inflammation. Early studies tested TRIV-509 on skin samples from patients and showed positive effects without serious side effects. Although complete safety data from human trials is not yet available, this treatment is now in Phase 2 trials. This phase primarily focuses on safety, so researchers are carefully monitoring for any side effects. While detailed results from human tests are not fully available, the ongoing study aims to ensure the treatment's safety for participants. ^{1 2 3 4 5}

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

Unlike the standard treatments for atopic dermatitis, which often involve topical steroids or immunosuppressants, TRIV-509 is unique because it targets specific pathways in the immune system to reduce inflammation more precisely. This innovative approach might minimize the side effects commonly associated with current treatments. Additionally, TRIV-509's ability to potentially offer faster relief makes it an exciting development for those suffering from this chronic skin condition. Researchers are hopeful that TRIV-509 could represent a new, more effective option for managing atopic dermatitis.

What evidence suggests that TRIV-509 might be an effective treatment for atopic dermatitis?

Research suggests that TRIV-509 might help treat atopic dermatitis, a common skin condition. Studies have shown that it can reduce skin thickening by 14% to 28% in some patients. It also strengthens the skin's natural barrier, which is crucial for maintaining healthy skin. TRIV-509 blocks two proteins, KLK5 and KLK7, involved in skin inflammation and irritation. By targeting these proteins, TRIV-509 may lessen symptoms like itchiness and redness. Although initial findings are promising, more research is needed to confirm its effectiveness. Participants in this trial will receive either TRIV-509 followed by a placebo or a placebo followed by TRIV-509 to further evaluate its potential benefits. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Adults with moderate to severe, active and symptomatic atopic dermatitis can join this study. Participants will be randomly assigned to receive either TRIV-509 or a placebo, and after 16 weeks, they'll switch to the other treatment.

Inclusion Criteria

I have active and noticeable Alzheimer's disease symptoms.

I have atopic dermatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive 4 doses of the study intervention (TRIV-509 or placebo) and at Week 16 cross over to receive 4 doses of the other intervention

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TRIV-509

Trial Overview

The trial is testing TRIV-509's effectiveness in treating atopic dermatitis compared to a placebo. Each participant will experience both treatments due to the crossover design of the study over a period of up to 57 weeks.

How Is the Trial Designed?

Group I: First TRIV-509 then Placebo Experimental Treatment 2 Interventions

Group II: First Placebo then TRIV-509 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Triveni Bio

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07167758

A Study Evaluating TRIV-509 in 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 ...

2.

triveni.bio

triveni.bio/triveni-doses-first-subject-in-global-phase-2-proof-of-concept-study-of-triv-509-in-atopic-dermatitis-presents-translational-data-at-2025-eadv-congress-demonstrating-novel-biology-in-patient-samples/

Triveni Doses First Subject in Global Phase 2 Proof of ...

Phase 2 atopic dermatitis (AD) study advances TRIV-509, a differentiated anti-KLK5/7 antibody with the potential to deliver a new level of ...

3.

dermatologytimes.com

dermatologytimes.com/view/triveni-bio-doses-first-patient-in-phase-2-trial-of-triv-509-for-atopic-dermatitis

Triveni Bio Doses First Patient in Phase 2 Trial of TRIV-509 ...

Epidermal thickness reduction: TRIV-509 reduced epidermal hyperplasia by 14% to 28% in 2 of the 3 patient samples. Decreased keratinocyte ...

4.

livderm.org

livderm.org/articles/triveni-bio-begins-phase-2-trial-of-triv-509-in-atopic-dermatitis/

Triveni Bio Begins Phase 2 Trial of TRIV-509 in Atopic ...

The findings demonstrated that TRIV-509 rapidly improved barrier integrity, reduced epidermal thickness, normalized keratinocyte proliferation, ...

5.

prnewswire.com

prnewswire.com/news-releases/triveni-doses-first-subject-in-global-phase-2-proof-of-concept-study-of-triv-509-in-atopic-dermatitis-presents-translational-data-at-2025-eadv-congress-demonstrating-novel-biology-in-patient-samples-302563730.html

Triveni Doses First Subject in Global Phase 2 Proof of ...

The presentation, titled, "TRIV-509, a dual inhibitor of KLK5 and KLK7, normalizes epidermal hyper-proliferation, improves barrier integrity and ...

6.

triveni.bio

triveni.bio/triveni-bio-doses-first-healthy-volunteers-in-clinical-trial-for-triv-509-coinciding-with-preclinical-data-presentations-further-validating-novel-kallikrein-5-7-biology-in-atopic-dermatitis/

Triveni Bio Doses First Healthy Volunteers in Clinical Trial ...

TRIV-509 data presented at SID showed rapid improvement in skin barrier integrity and epidermal differentiation in AD patient explants. The ...

7.

withpower.com

withpower.com/trial/phase-2-dermatitis-atopic-8-2025-d8ad3

TRIV-509 for Atopic Dermatitis

This Phase 2 medical study run by Triveni Bio is evaluating whether TRIV-509 will have tolerable side effects & efficacy for patients with Atopic Dermatitis ...