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.
調査の概要
詳細な説明
The study will be carried out in a single study site located in Germany.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Anna Nilson
- 電話番号：+358503106846
- メール：anna.nilson@desentum.fi
研究連絡先のバックアップ
- 名前：Birgitta Kalvi
- 電話番号：+358453199009
- メール：birgitta.kalvi@desentum.fi
研究場所
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Hanover、ドイツ、30625
- 募集
- Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
-
コンタクト：
- Philipp Badorrek
- 電話番号：+49 511 5350-8130
- メール：philipp.badorrek@item.fraunhofer.de
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
プラセボコンパレーター：Placebo for cohort 1
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
実験的：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 |
|
プラセボコンパレーター：Placebo for cohort 2
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
実験的：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 |
|
プラセボコンパレーター：Placebo for cohort 3
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
|
実験的：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 |
|
プラセボコンパレーター：Placebo for cohort 4
Weekly subcutaneous administration of Placebo for 10 weeks |
Placebo to match subcutaneous injection of DM-101PX |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Emergent Adverse Events
時間枠：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
|
|
Adverse Events of Special Interest
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjects Reaching the Maximum Intended Dose
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Philipp Badorrek, MD、Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- DM-101-C-005
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All individual participant data that underlie publicly available results will be considered for sharing
IPD 共有時間枠
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.
IPD 共有アクセス基準
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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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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