A Phase 1 interventional study of DM-101PX and Placebo in Birch Pollen Allergy, sponsored by Desentum Oy. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Desentum Oy · Phase 1, Interventional, and Treatment
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.
The study will be carried out in a single study site located in Germany.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's planned enrollment of 40 is below the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →Desentum Oy is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: DM-101PX
Weekly subcutaneous administration of Placebo for 10 weeks
Biological: Placebo
Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with varying injection volumes
Biological: DM-101PX
Weekly subcutaneous administration of Placebo for 10 weeks
Biological: Placebo
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.
Biological: DM-101PX
Weekly subcutaneous administration of Placebo for 10 weeks
Biological: Placebo
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.
Biological: DM-101PX
Weekly subcutaneous administration of Placebo for 10 weeks
Biological: Placebo
Subcutaneous injection of DM-101PX
Placebo to match subcutaneous injection of DM-101PX
Treatment Emergent Adverse Events
Occurrence of treatment emergent adverse events
Time frame: From the first dose to until 3 months from the last dose
Adverse Events of Special Interest
Occurrence of local injection site reactions and systemic allergic reactions
Time frame: From the first dose to until 3 months from the last dose
Subjects Reaching the Maximum Intended Dose
Number of subjects in each cohort who reach the maximum intended dose
Time frame: Through the treatment period, an average of 10 weeks
Change in blood allergy biomarker levels
Change in the levels of Bet v 1-specific IgE, IgG1 and IgG4
Time frame: From baseline to 3 and 12 weeks, after completion of treatment
Plan to share: Yes — All individual participant data that underlie publicly available results will be considered for sharing
Time frame: 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.
Access criteria: 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.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.
Of 16 phase 1 interventional studies under Rhinitis, Allergic, Seasonal, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 9. This study's planned 5 months is close to that.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Oct 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: DM-101PX
Rhinitis, Allergic, Seasonal →
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