TEV-48574 for Asthma

No longer recruiting at 110 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must be taking: Inhaled corticosteroids, Long-acting beta-agonists

Disqualifiers: Pregnancy, Lactation, Recent vaccines, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether TEV-48574, an experimental treatment, can manage asthma more effectively than a placebo. The researchers aim to determine if this treatment can prevent severe asthma from becoming uncontrolled in individuals not fully managed by their current inhalers. Individuals with asthma for over a year and at least one flare-up in the past 18 months might be suitable for this study. Participants will receive either the new treatment or a placebo every two weeks for up to 30 weeks. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in asthma care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that any treatments that could interfere with the study are excluded, so it's best to discuss your specific medications with the study investigator.

Is there any evidence suggesting that TEV-48574 is likely to be safe for humans?

Research has shown that TEV-48574 is generally safe for people. One study found that both healthy individuals and those with asthma tolerated TEV-48574 well, experiencing only minor side effects. Another study examined its use in conditions like ulcerative colitis and Crohn's disease and also found it safe during early treatment stages.

These findings suggest that TEV-48574 might be safe for people with asthma as well. However, safety can vary among individuals. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, TEV-48574 offers a unique approach. It targets specific immune pathways, potentially altering the underlying inflammatory processes that cause asthma symptoms. Researchers are excited about TEV-48574 because it could provide a more targeted and effective option for asthma management, especially for patients who don't respond well to current therapies. Additionally, its administration every two weeks might simplify treatment regimens, improving adherence and outcomes for patients.

What evidence suggests that TEV-48574 might be an effective treatment for severe asthma?

Research has shown that TEV-48574, also known as duvakitug, may reduce inflammation and scarring in animal studies of colitis. This drug is an antibody that targets TL1A, a protein involved in inflammation. In patient studies, TEV-48574 was safe, with no major safety issues. Early evidence suggests it helps control inflammation in ulcerative colitis and Crohn's disease, both inflammatory conditions. Although these findings are promising for asthma treatment, more research is needed to confirm its effectiveness specifically for asthma. Participants in this trial will receive either TEV-48574 or a placebo to further evaluate its safety and effectiveness. ^{3 4 6 7 8}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training

The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.

The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TEV-48574 or placebo every 2 weeks for a total of 8 doses over 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-48574

How Is the Trial Designed?

Group I: TEV-48574 Experimental Treatment 1 Intervention

Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05668013

A Study to Evaluate the Long-Term Effect of TEV-48574 in ... The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i77/7966998

OP40 Duvakitug (TEV-48574), an anti-TL1a monoclonal ... Duvakitug has demonstrated reduced inflammation and fibrosis in colitis animal models.1 Few data are available for the potential of anti-TL1A ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05499130

NCT05499130 | A Study to Test the Effect of TEV-48574 in ... The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

4. academic.oup.com academic.oup.com/ecco-jcc/article/18/Supplement_1/i1899/7587191

P1061 TEV-48574, an anti-TL1A antibody in development for ... TEV-48574 administered every 2 weeks over 16 weeks demonstrated a favourable safety and tolerability profile with no emerging safety signals or evidence of ...

5. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-and-Sanofi-Present-New-Positive-Phase-2b-Study-Results-at-ECCO-2025-ReinforcingBest-in-Class-Potential-of-Duvakitug-Anti-TL1A-in-Ulcerative-Colitis-and-Crohns-Disease/default.aspx

Teva and Sanofi Present New Positive Phase 2b Study ... Duvakitug (TEV-48574), an anti-TL1A monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults ...

6. tevausa.com tevausa.com/news-and-media/press-releases/teva-presents-new-data-supporting-safety-tolerability-and-target-engagement-of-anti-tl1a-tev-574-anti/

Teva Presents New Data Supporting Safety, Tolerability ... (2024). P1061 TEV-48574, an anti-TL1A antibody in development for use in IBD, is safe and well tolerated following 16 weeks of subcutaneous ...

7. academic.oup.com academic.oup.com/ecco-jcc/article/18/Supplement_1/i1206/7586597

P633 First-in-Human Pharmacokinetic and Safety Study of an ... TEV-48574 was well tolerated at all tested doses in healthy subjects and participants with asthma, with dose proportional increases in exposure and minimal ...

8. researchgate.net researchgate.net/publication/377680915_P998_Phase_2_basket_design_study_evaluating_the_efficacy_and_safety_of_an_anti-TL1A_antibody_TEV-48574_in_moderate_to_severe_ulcerative_colitis_or_Crohn's_Disease_RELIEVE_UCCD

P998 Phase 2 basket design study evaluating the efficacy ... P998 Phase 2 basket design study evaluating the efficacy and safety of an anti-TL1A antibody (TEV-48574) in moderate to severe ulcerative colitis or Crohn's ...