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HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP

Clinical trials are studying HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP in adults with moderate or severe asthma. These studies aim to evaluate safety, tolerability, pharmacokinetics, immunogenicity, and efficacy. The main trial listed here is a phase 2 study in adult participants.

Table of Contents

Trial overview

The listed study is a Phase 2, randomized, double-blind, placebo-controlled trial of HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP, also listed as WIN378, in adults with moderate or severe asthma.[1]

The study is described as interventional, which means participants receive a study treatment as part of the research plan.[1]

Study design and treatment groups

This trial compares WIN378, given as a 300 mg subcutaneous dose, with a matching placebo for WIN378.[1]

Randomized means people are assigned by chance to a study group, and double-blind means the participant and study team do not know which treatment is given during the study.[1]

Who can participate

The trial is for adult participants with moderate or severe asthma.[1]

The source data do not list more detailed entry rules, so exact eligibility would depend on the full study screening process.[1]

What the trial measures

The main safety measures are treatment-emergent adverse events, treatment-emergent serious adverse events, vital signs, laboratory assessments, and electrocardiogram (ECG) findings.[1]

The trial also measures WIN378 pharmacokinetics, which means how the body handles the study drug over time, and anti-drug antibodies, which are immune proteins that may react against the treatment.[1]

These outcomes are tracked during the study from Week 0 (Day 1) to Week 60.[1]

Trial goals and what they mean

The brief summary says the study aims to evaluate safety and tolerability of WIN378.[1]

Tolerability means how well participants can take the study treatment without major problems that stop treatment.[1]

The study also aims to describe pharmacokinetics and immunogenicity, meaning it looks at drug levels in the body and whether the immune system makes antibodies against the treatment.[1]

Trial status and enrollment

The study status is listed as Authorised.[1]

The planned enrollment is 211 participants, which is the number of people the trial aims to include.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521391-58-00 Phase 2 Asthma Authorised 211

FAQ

  • What is being studied in the HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP trials? The trial is studying WIN378, which is listed as HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP, in adults with asthma. It compares the study drug with a matching placebo.
  • Who can take part in these trials? The listed trial is for adult participants with moderate or severe asthma. Participation depends on the study’s rules and the trial team’s screening process.
  • What phase is the trial? The trial is a Phase 2 study. Phase 2 trials usually look more closely at safety and early signs of whether a treatment may help.
  • What does the trial measure? The study measures side effects, serious side effects, vital signs, lab tests, ECG results, drug levels in the body, and anti-drug antibodies. Anti-drug antibodies are immune proteins that may react against the study drug.
  • What is the goal of the trial? The main goals are to evaluate safety and tolerability, and to describe pharmacokinetics and immunogenicity. Pharmacokinetics means how the body handles the drug over time, and immunogenicity means whether the body makes an immune response to it.

Ongoing Clinical Trials on HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST TSLP

  • Testing WIN378 Safety and Effects in Adults with Moderate or Severe Asthma

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Spain Sweden

Glossary

  • Asthma: A long-term lung condition that can cause wheezing, cough, chest tightness, and trouble breathing.
  • Moderate or severe asthma: Asthma that causes more than mild symptoms and may need stronger treatment or closer follow-up.
  • Phase 2: A mid-stage clinical trial that looks at safety and early evidence of benefit in a group of participants.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the results fair.
  • Double-blind: Neither the participants nor the study staff know who receives the study drug or placebo during the trial.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine.
  • Pharmacokinetics: How the body absorbs, moves, breaks down, and removes a drug.
  • Immunogenicity: Whether the immune system makes antibodies against the study drug.
  • Anti-drug antibodies: Antibodies made by the body that can react to the study treatment.
  • Electrocardiogram (ECG): A test that records the electrical activity of the heart.
  • Treatment-emergent adverse events: Health problems that start or get worse after the study treatment begins.

References

  1. https://clinicaltrials.gov/study/2025-521391-58-00