Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy (UPSIT)
A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability And Pharmacodynamics of Subcutaneous Immunotherapy With DM-101PX in Subjects With Birch Pollen Allergy
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of DM-101-PX compared to placebo in birch pollen allergic adults. As an secondary objectives, the trial will also assess the number of participants receiving the maximum intended DM-101PX dose and to assess the effect of treatment with DM-101PX compared with placebo on blood allergy biomarkers. Expanded access to the study treatment is not available.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study will be carried out in a single study site located in Germany.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anna Nilson
- Numéro de téléphone: +358503106846
- E-mail: anna.nilson@desentum.fi
Sauvegarde des contacts de l'étude
- Nom: Birgitta Kalvi
- Numéro de téléphone: +358453199009
- E-mail: birgitta.kalvi@desentum.fi
Lieux d'étude
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Hanover, Allemagne, 30625
- Recrutement
- Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
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Contact:
- Philipp Badorrek
- Numéro de téléphone: +49 511 5350-8130
- E-mail: philipp.badorrek@item.fraunhofer.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or female, aged 18 to 65 years
- Good general health
- A documented clinical history of moderate to severe birch pollen-induced allergic rhinitis or rhinoconjunctivitis for at least 2 years with symptoms that interfere with daily activities or sleep
- Bet v 1-specific IgE ≥0.7 kU/L (class 2) measured by ImmunoCAP® performed at the trial site at Screening or within 12 months prior to Screening
- Positive SPT to Birch pollen whole allergen extract with a wheal diameter ≥3 mm (average of longest and orthogonal), with the negative control wheal diameter <2 mm and the positive (histamine) control wheal diameter ≥3 mm, performed at the trial site at Screening or within 12 months prior to Screening
- Body weight ≥50 kg and body mass index within the range 18-35 kg/m2
Exclusion Criteria:
- History or findings on physical examination of any significant disease or disorder which, in the opinion of the investigator, may put the individual at risk because of participation in the trial, influence the results of the trial or the participant's ability to participate in the trial
- Significant rhinitis, sinusitis, and/or symptomatic respiratory allergy due to regular contact with allergens other than birch pollen that are expected to potentially interfere with the trial assessments, as assessed by the investigator
- Persistent asthma that requires GINA Step 2 or higher treatment during the trial period, or required treatment within 4 weeks prior to Screening
- History of uncontrolled asthma according to GINA classification in the 6 months prior to Screening or history of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before Screening, or a life-threatening asthma attack (eg, one requiring intubation and mechanical ventilation) at any time in the past
- Forced Expiratory Volume in one second (FEV1) <70 % of predicted, regardless of asthma status at Screening
- History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or greater, according to the WAO classification (2024, see Section 12.5), due to any cause
- History of acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation, including polyethylene glycol, or severe or significant allergies that in the opinion of the investigator could represent a substantial risk to the individual
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: DM-101PX for cohort 1
Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with slightly varying injection volumes. |
Subcutaneous injection of DM-101PX |
|
Comparateur placebo: Placebo for cohort 1
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Expérimental: Experimental: DM-101PX for cohort 2
Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with varying injection volumes |
Subcutaneous injection of DM-101PX |
|
Comparateur placebo: Placebo for cohort 2
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Expérimental: Experimental: DM-101PX for cohort 3
Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with varying injection volumes. |
Subcutaneous injection of DM-101PX |
|
Comparateur placebo: Placebo for cohort 3
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Expérimental: Experimental: DM-101PX for cohort 4
Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with constant varying injection volume. |
Subcutaneous injection of DM-101PX |
|
Comparateur placebo: Placebo for cohort 4
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Emergent Adverse Events
Délai: From the first dose to until 3 months from the last dose
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Occurrence of treatment emergent adverse events |
From the first dose to until 3 months from the last dose
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Adverse Events of Special Interest
Délai: From the first dose to until 3 months from the last dose
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Occurrence of local injection site reactions and systemic allergic reactions |
From the first dose to until 3 months from the last dose
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjects Reaching the Maximum Intended Dose
Délai: Through the treatment period, an average of 10 weeks
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Number of subjects in each cohort who reach the maximum intended dose |
Through the treatment period, an average of 10 weeks
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Change in blood allergy biomarker levels
Délai: From baseline to 3 and 12 weeks, after completion of treatment
|
Change in the levels of Bet v 1-specific IgE, IgG1 and IgG4 |
From baseline to 3 and 12 weeks, after completion of treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Philipp Badorrek, MD, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DM-101-C-005
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
All individual participant data that underlie publicly available results will be considered for sharing
Délai de partage IPD
Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant reidentification.
Critères d'accès au partage IPD
Qualified researchers may request access to patient level data underlying the publication: patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g. FDA, EMA), has the legal authority to share the data, and has made the study results publicly available. Requests from qualified researchers will be reviewed by the Sponsor, and data will be shared only for scientifically sound research purposes, subject to a signed data sharing agreement and in compliance with applicable data protection legislation and participant consent.
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