Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

NCT01902992 | Completed Phase 3 DMC

• 2 other identifiers: CDPG103ADE012011-004185-14
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 35

Brief Summary

This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Combined Symptom and Medication Score (SMS)

  The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.

  From the start of treatment until the end of the relevant pollen exposition time.

Secondary Outcomes (3)

• Combined Symptom and Medication Score (SMS)

  date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months

• Onset of action (patient's assessment)

  date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months

• Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)

  Visits 2, 4, 6, and 7

Study Arms (2)

Depiquick® Birch

EXPERIMENTAL

At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.

Drug: Depiquick Birch (DPG103)

Placebo

PLACEBO COMPARATOR

At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.

Drug: Placebo

Interventions

Depiquick Birch (DPG103) DRUG

Depiquick® Birch

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must experience significant allergic symptoms on visit 2
• Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
• Specific IgE against birch allergens (CAP RAST ≥ 2)

You may not qualify if:

• History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
• FEV1 or PEF value ≤ 80 %
• Persistent asthma (GINA ≥ 2)

Sponsors & Collaborators

• Novartis: lead

Study Sites (35)

Novartis Investigative Site

Aachen, 52074, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

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Novartis Investigative Site

Augsburg, 86179, Germany

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Novartis Investigative Site

Bad Wildbad, 75323, Germany

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Novartis Investigative Site

Bad Wörishofen, 86825, Germany

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Novartis Investigative Site

Bensheim, 64625, Germany

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Novartis Investigative Site

Berlin, 13057, Germany

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Novartis Investigative Site

Berlin, 13187, Germany

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Novartis Investigative Site

Berlin, 14050, Germany

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Novartis Investigative Site

Bochum, 44803, Germany

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Novartis Investigative Site

Bonn, 53105, Germany

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Novartis Investigative Site

Chemnitz, 09130, Germany

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Novartis Investigative Site

Delitzsch, 04509, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Duisburg, 47051, Germany

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Novartis Investigative Site

Dülmen, 48249, Germany

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Novartis Investigative Site

Frankfurt, 60389, Germany

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Novartis Investigative Site

Gera, 07548, Germany

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Novartis Investigative Site

Hanover, 30159, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

Leipzig, 04103, Germany

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Novartis Investigative Site

Leipzig, 04275, Germany

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Novartis Investigative Site

Leipzig, 04357, Germany

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Novartis Investigative Site

Lübeck, 23538, Germany

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Novartis Investigative Site

Münster, 48143, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Neunkirchen, 66538, Germany

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Novartis Investigative Site

Nidderau, 61130, Germany

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Novartis Investigative Site

Oberhausen, 46145, Germany

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Novartis Investigative Site

Osnabrück, 49074, Germany

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Novartis Investigative Site

Rodgau, 63110, Germany

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Novartis Investigative Site

Wallenhorst, 49134, Germany

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Novartis Investigative Site

Wiesbaden, 64191, Germany

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Novartis Investigative Site

Wiesbaden, 65183, Germany

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Novartis Investigative Site

Witten, 58452, Germany

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: July 19, 2013
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

DE (35)