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Rupatadine

Clinical trials investigating Rupatadine are included in studies of allergic rhinitis, allergic rhinoconjunctivitis, and epidermolysis bullosa. These trials look at treatment effect, safety, and symptom control in different patient groups, including adolescents, adults, and children with severe skin disease. Some studies use Rupatadine as a comparator or supportive treatment within larger trial plans.

Table of contents

Clinical trials overview

The trial data show two Phase 3 studies that include Rupatadine in the intervention lists.[1][2] Both studies are interventional, which means researchers assign treatments and then measure results.[1][2]

One study is in people with severe inherited skin disease, and the other is in people with birch pollen-related allergy symptoms.[1][2] In both trials, Rupatadine appears among several study medicines or comparators rather than as the only focus.[1][2]

Birch pollen allergy study

The completed multicentre trial studied adolescents and adults with birch pollen-induced allergic rhinitis or allergic rhinoconjunctivitis.[2] These conditions mean allergy symptoms that affect the nose, and sometimes both the nose and the eyes.[2]

This study was described as prospective, randomized, double-blind, and placebo-controlled, which means people were followed forward in time, assigned by chance, and compared with a placebo in a way that reduced bias.[2] The main goal was to assess the clinical impact of T502 treatment during the peak birch pollen season, using the mean daily Combined Symptom and Medication Score (CSMS).[2]

Rupatadine was listed among the interventions in this study, together with several allergy medicines, eye drops, nasal sprays, and placebo.[2] The trial also included a mannan-conjugated birch pollen allergoid, which is the main investigational treatment named in the study title and summary.[2]

Epidermolysis bullosa study

The authorised Phase 3 study NCT05464381 is investigating treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB).[1] These are rare inherited skin disorders that cause very fragile skin and painful wounds.[1]

The study aims to compare the safety and efficacy of allo-APZ2-OTS given by vein in people with RDEB against placebo.[1] It also includes an additional open-label arm, which means the treatment is given without blinding, to study safety and efficacy in people with JEB and in RDEB patients younger than 1 year.[1]

Rupatadine is listed in the intervention set for this study together with placebo and many other medicines, including antihistamines, steroids, and other supportive treatments.[1] The trial data do not say that Rupatadine is the main study drug, but they show it is part of the broader treatment list being tracked in the trial.[1]

Who can participate

Eligibility depends on the study.[1][2] In the allergy study, participants are adolescents and adults with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.[2]

In the skin disease study, participants have RDEB or JEB, and the open-label part also includes RDEB patients younger than 1 year.[1] The trial data do not provide more detailed inclusion or exclusion rules, so only these groups can be confirmed from the source material.[1]

Main outcomes being measured

The allergy study measures the mean daily CSMS over the peak birch pollen season in 2025, comparing the placebo group with the active treatment group.[2] This score combines symptoms and the need for medicine, so it gives a practical picture of how well the treatment helps everyday allergy control.[2]

The skin disease study measures the proportion of subjects with RDEB aged 1 year or older who have complete target wound closure at Month 6, with confirmation 2 weeks later.[1] In simple terms, researchers want to know how many patients have full healing of the wound they are following.[1]

The brief summary for the skin disease trial also states that the study is looking at safety and efficacy, meaning whether the treatment can be used without major problems and whether it helps the condition.[1] The allergy study likewise aims to understand the clinical effect of the treatment during the pollen season.[2]

Trial status and size

The epidermolysis bullosa trial is authorised and has an enrollment of 167 participants.[1] The birch pollen allergy trial is completed and has an enrollment of 360 participants.[2]

These two studies show that Rupatadine appears in very different research settings, from rare skin disease to seasonal allergy research.[1][2] The trial records focus on group comparisons, symptom scores, and wound healing rather than on a drug monograph or detailed pharmacology.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05464381 Phase 3 Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB) Authorised 167
2024-515717-17-00 Phase 3 Birch pollen-induced allergic rhinitis and allergic rhinoconjunctivitis Completed 360

FAQ

  • What conditions are being studied in trials that include Rupatadine? The trial data include birch pollen-induced allergic rhinitis and allergic rhinoconjunctivitis, as well as recessive dystrophic epidermolysis bullosa and junctional epidermolysis bullosa. Rupatadine appears in the treatment lists for these studies.
  • Who may take part in these Rupatadine-related trials? One study includes adolescents and adults with birch pollen-related allergy symptoms. Another study includes people with epidermolysis bullosa, including patients with RDEB and JEB, and also a group with RDEB under 1 year of age.
  • What phase are the Rupatadine-related trials? Both trials listed are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups of people to learn more about how well it works and how safe it is.
  • What are the main outcomes being measured? One trial measures complete wound closure at Month 6 in people with RDEB. The allergy trial measures the mean daily Combined Symptom and Medication Score during the peak birch pollen season.
  • Are these trials focused only on Rupatadine? No. Rupatadine is listed among several treatments in the trial data, but the main goals of the studies are broader. They focus on comparing active treatment and placebo, and on measuring symptoms, medication use, and wound healing.

Ongoing Clinical Trials on Rupatadine

  • Study on ABCB5+ MSCs for Recessive Dystrophic and Junctional Epidermolysis Bullosa Patients

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Croatia Denmark France Germany Greece +6

  • Study on the Effects of Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis

    Not recruiting

    1 1 1
    Investigated drugs:
    Germany

Glossary

  • Phase 3: A late stage of a clinical trial. It usually includes more people and helps researchers learn how well a treatment works and how safe it is.
  • Interventional study: A study where participants receive a treatment, placebo, or another intervention so researchers can compare results.
  • Placebo: A look-alike treatment with no active study medicine. It helps show whether the real treatment works better than no active treatment.
  • Randomized: Participants are assigned by chance to different study groups. This helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team know who gets the active treatment or placebo during the study. This helps reduce bias.
  • Allergic rhinitis: Nasal allergy symptoms such as sneezing, runny nose, and itching.
  • Rhinoconjunctivitis: Allergy symptoms that affect both the nose and the eyes.
  • Epidermolysis bullosa: A group of rare skin disorders that cause very fragile skin and blisters.
  • Recessive Dystrophic Epidermolysis Bullosa (RDEB): A severe inherited form of epidermolysis bullosa that can cause painful wounds and fragile skin.
  • Junctional Epidermolysis Bullosa (JEB): Another inherited form of epidermolysis bullosa that causes fragile skin and blistering.
  • Primary outcome: The main result the study is designed to measure.
  • Combined Symptom and Medication Score (CSMS): A score that combines allergy symptoms and the need for rescue medication. Lower or better scores may mean better control of the condition.

References

  1. https://clinicaltrials.eu/trial/36922/
  2. https://clinicaltrials.gov/study/2024-515717-17-00