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Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Study acronym: MM09-SIT-023
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Primary completion date: Jan 2024 to Dec 2026v8 Show 5 more changesShow less
    • Study sites: 18 to 32
    • Study completion date: Dec 2025 to Dec 2026
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description revised
  2. Minor Study sites: 17 to 18
    • Eligibility criteria expanded, about 75 words
    • Collaborators expanded, about 3 words
    v7
  3. Notable Primary completion date: Jan 2022 to Jan 2024
    • Study completion date: Apr 2022 to Dec 2025
    • Site details revised at 2 of 17 sites
    • Eligibility criteria shortened, about 5 words
    v6
  4. Minor Re-verified, no change to tracked fieldsv5
  5. Minor Secondary endpoints: details revised at 1 of 7 entriesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Primary completion date: Jan 2021 to Jan 2022
    • Secondary endpoints revised (7)
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 21 to 17
    • Start date changed from estimate of Sep 2020 to Oct 6, 2020
    • Secondary endpoints: details revised at 1 of 7 entries
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
956 trials monitored
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A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
Trial Details
NCT Number NCT04435990
Lead Sponsor Inmunotek S.L.
Collaborators: BioClever 2005 S.L.
Conditions
(from sponsor)
Rhinitis, Allergic, Rhinoconjunctivitis, Asthma, Allergic
Related terms Asthma, Hypersensitivity, Rhinitis, Allergic
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov