Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma

NCT01634958 | Completed Phase 2 DMC

• 2 other identifiers: 6043-PG-PSC-1922012-000416-28
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 2

Brief Summary

Specific immunotherapy for IgE mediated sensitization to grass pollen 4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.

Conditions

Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma; Sensitization Against Phleum Pratense Pollen; Dose-Finding Study

Keywords

Allergic Rhinitis; Hayfever; Immunotherapy; Dose-Finding-Study

Outcome Measures

Primary Outcomes (1)

• Conjunctival Provocation Test (CPT)

  Comparison between dosage groups: percentage of patients who need an increased amount of allergen to provoke a positive CPT at the end of the treatment (comparison slope of efficacy). It is expected that at the end of the study higher doses are necessary to provoke a positive CPT. According to the EMA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

  At screening and after approx. 22 weeks (EoS)

Secondary Outcomes (4)

• Conjunctival Provocation Test (CPT)

  after approx. 22 weeks (EoS)

• Overall assessment of safety (tolerability) at the end of the study

  after approx. 22 weeks (EoS)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  at 4-weekly intervals (retrospectively at study visits)

• Patient diary: Allergy specific symptoms and concommitant medication (rescue m.) for 48hrs after application of IMP

  48hrs every 4 weeks after each application of IMP

Study Arms (4)

10.000 DPP/ml suspension for s.c. inj.

EXPERIMENTAL

Biological: Depigoid Phleum

5.000 DPP/ml suspension for s.c. inj.

EXPERIMENTAL

Biological: Depigoid Phleum

1.000 DPP/ml suspension for s.c. inj.

EXPERIMENTAL

Biological: Depigoid Phleum

100 DPP/ml suspension for s.c. inj.

EXPERIMENTAL

Biological: Depigoid Phleum

Interventions

Depigoid Phleum BIOLOGICAL

Suspension for subcutaneous injection Build-up phase (day 1): 0,1mL + 0,2mL + 0,2mL s.c.injections in intervals of 30 minutes Maintenance phase: 5x single s.c. injection of 0,5mL every 4 weeks

Also known as: Depigoid (R) Phleum, Depigmented and glutaraldehyde polymerized extract of 100% phleum pratense pollen adsorbed onto aluminium hydroxide)

1.000 DPP/ml suspension for s.c. inj.; 10.000 DPP/ml suspension for s.c. inj.; 100 DPP/ml suspension for s.c. inj.; 5.000 DPP/ml suspension for s.c. inj.

Eligibility Criteria

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

You may qualify if:

• appropriately signed and dated ICON prior to study specific action
• IgE-mediated Sensitization against grass pollen
• Perception of disease activity of at least 30 mm on a 100 mm VAS
• FEV1 or a PEFR value \> 80% of predicted normal value
• Allergic rhinitis and/or rhinoconjunctivitis symptoms (at least 2 years) with or without intermittent asthma symptoms verified by:
• suggestive medical history AND
• specific IgE against grass pollen with CAP-RAST ≥ 2 AND
• a positive SPT (wheal diameter ≥ 3 mm) AND
• a positive CPT for grass pollen
• Patients with co-allergies are allowed to enter the study:
• being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens
• with CAP-RAST co-allergen \< grass (detailed specifications given for Birch, HDM, animal dander, other country specific allergens)
• All other co-allergens: difference in CAP RAST co-allergen to grass of ≥ 2 and an SPT wheal diameter co-allergen \< grass
• Females of non-childbearing potential must be postmenopausal for at least
• year or surgically sterilized

You may not qualify if:

• Acute or chronic infectious conjunctivitis
• History of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites)
• Patients are not allowed to enter into the study:
• with typical symptoms against co-allergens such as tree or weed pollen, HDM, cat and dog, and other country specific allergens
• with CAP-RAST co-allergen ≥ grass
• Persistent asthma, according to Global Initiative for Asthma (GINA)
• Acute or chronic inflammatory or infectious airways disease
• Chronic structural disease of the lung (e.g., emphysema or bronchiectasis)
• Autoimmune and/or immune deficiency
• Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism)
• Severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to: cardiovascular insufficiency, severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
• Active malignant disease during the previous 5 years
• Significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient
• Abuse of alcohol, drugs or medications within the past year
• Severe psychiatric, psychological or neurological disorder

Sponsors & Collaborators

• Leti Pharma GmbH: lead

Study Sites (2)

Hippke, Ear-Nose-Throat specialist

Berlin, 10117, Germany

Location

Zentrum für Rhinologie und Allergie

Wiesbaden, 65183, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Oliver Pfaar, PD Dr. med.

  Centre for Rhinology and Allergology of University Hospital Mannheim

  PRINCIPAL INVESTIGATOR

• Angelika Sager, Dr. med.

  Leti Pharma GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

DE (2)