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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study will be carried out in a single study site located in Germany.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Anna Nilson
- Numero di telefono: +358503106846
- Email: anna.nilson@desentum.fi
Backup dei contatti dello studio
- Nome: Birgitta Kalvi
- Numero di telefono: +358453199009
- Email: birgitta.kalvi@desentum.fi
Luoghi di studio
-
-
-
Hanover, Germania, 30625
- Reclutamento
- Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
-
Contatto:
- Philipp Badorrek
- Numero di telefono: +49 511 5350-8130
- Email: philipp.badorrek@item.fraunhofer.de
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Comparatore placebo: Placebo for cohort 1
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Sperimentale: 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 |
|
Comparatore placebo: Placebo for cohort 2
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Sperimentale: 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 |
|
Comparatore placebo: Placebo for cohort 3
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
Sperimentale: 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 |
|
Comparatore placebo: Placebo for cohort 4
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment Emergent Adverse Events
Lasso di tempo: From the first dose to until 3 months from the last dose
|
Occurrence of treatment emergent adverse events |
From the first dose to until 3 months from the last dose
|
|
Adverse Events of Special Interest
Lasso di tempo: From the first dose to until 3 months from the last dose
|
Occurrence of local injection site reactions and systemic allergic reactions |
From the first dose to until 3 months from the last dose
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjects Reaching the Maximum Intended Dose
Lasso di tempo: Through the treatment period, an average of 10 weeks
|
Number of subjects in each cohort who reach the maximum intended dose |
Through the treatment period, an average of 10 weeks
|
|
Change in blood allergy biomarker levels
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Philipp Badorrek, MD, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- DM-101-C-005
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
All individual participant data that underlie publicly available results will be considered for sharing
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .