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Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent AsthmaPhase 2NCT01634958

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

A Phase 2 study testing Depigoid Phleum in people with Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma and Sensitization Against Phleum Pratense Pollen, run by Leti Pharma GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Depigoid Phleum
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
2 sitesGermany
Study dates
Oct 2012to Jun 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 1 year or surgically sterilized
  • Females of childbearing potential must be non-lactating, non-pregnant and must correctly use an effective method of contraception during the study.

Who cannot join

  • 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)
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  • 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
  • Immunotherapy against grass pollen within the last 5 years
  • Systemic and/or topical treatment with β-blockers within 1 wk prior to V2
  • Use of medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at V2
  • Use of tranquiliser or psychoactive drugs within 1 week prior to V1
  • Use of systemic corticosteroids within 3 months prior to V1
  • Immunization with vaccines within 7 days prior to V2
  • Expected non-compliance and/or no cooperation
  • Participation in another clinical study within 30 days prior to V2
  • Prior participation in this study
  • Employees at the investigational centre or first degree relative or partner of the investigator
  • Planed donation of germ cells, blood, organs or bone marrow during the course of the study
  • Contractually not capable
  • A positive pregnancy test at V1
  • Jurisdictional or governmentally institutionalised.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Hippke, Ear-Nose-Throat specialist

    Berlin, 10117

  • Zentrum für Rhinologie und Allergie

    Wiesbaden, 65183

Other trials in Germany

About this study

Official title: A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma

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.

Read the detailed description

This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly intervals 6x 0,5mL of one of 4 different concentrations of Depigoid Phleum. The study is performed outside the pollen season. Thus the aim of the study is not the therapeutic effect of the specific immunotherapy (effect on allergy specific symptoms during the pollen season) but the effect on the Conjunctival provocation test (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.

For the CPT increasing doses of Phleum pollen solutions are applied to the eye and characteristic symptoms (eye redness, weeping, itching or burning, and nose dripping/blockage) are assessed at each concentration: 0=absent, 1=mild, 2=moderate, 3=severe. At a score value of >=5/concentration the test is considered positive and finished.

It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.

Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is a very important parameter for the evaluation of the outcome of the study.

Being tested
Depigoid Phleum
Keywords
Allergic Rhinitis, Hayfever, Immunotherapy, Dose-Finding-Study
Medical subject headings
Rhinitis, Allergic, Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Depigoid PhleumBiological

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

    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

Study groups in NCT01634958
Study groupRoleWhat they receive
10.000 DPP/ml suspension for s.c. inj.ExperimentalNot described
Receives: Biological: Depigoid Phleum
5.000 DPP/ml suspension for s.c. inj.ExperimentalNot described
Receives: Biological: Depigoid Phleum
1.000 DPP/ml suspension for s.c. inj.ExperimentalNot described
Receives: Biological: Depigoid Phleum
100 DPP/ml suspension for s.c. inj.ExperimentalNot described
Receives: Biological: Depigoid Phleum

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At screening and after approx. 22 weeks (EoS)

Secondary outcomes (4)

  1. Conjunctival Provocation Test (CPT)

    Analysis of individual results for allergen amount

    Measured: after approx. 22 weeks (EoS)

  2. Overall assessment of safety (tolerability) at the end of the study

    At the end of the study investigator and patient will give their general overall impression on the safety of the study treatment on a 4-point scale (excellent, good, moderated, unacceptable).

    Results will be compared between dosage groups

    Measured: after approx. 22 weeks (EoS)

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

    AEs are recorded at the study visits (patients are questioned and the patient diary - where specific allergic symptoms should be recorded by the patients during 48hrs after each injection of IMP - is assessed by the investigator and AEs recorded in the CRF if applicable) and at any time of the study when site becomes aware of an Ae/SAE.

    AE/SAE rate is compared between treatment groups (safety profile. Also rates of local and systemic reactions will be calculated.

    Measured: at 4-weekly intervals (retrospectively at study visits)

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

    Symptoms: - at injection site, - of the skin (not injection site), - of the nose, - of the eyes, - of the lung/respiratory system, other symptoms Symptoms documented in the diary will be judged and assessed by the investigator and - if applicable - transcribed as AE into the CRF.

    Medication: Antihistaminics (eye drops, nose spray or tablet), Sultanol, oral corticosteroid and intake of other medication documented in the diary are to be transcribed to the CRF

    Measured: 48hrs every 4 weeks after each application of IMP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionApr 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01634958
Sponsor's protocol ID
6043-PG-PSC-192
Other IDs
2012-000416-28
Status last verified
Nov 2013
First submitted
3 Jul 2012
Last updated
19 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Depigoid Phleum in people with Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma and Sensitization Against Phleum Pratense Pollen, run by Leti Pharma GmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conjunctival Provocation Test (CPT) (time frame: At screening and after approx. 22 weeks (EoS)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01634958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.

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