Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00258635
• Date of registration: 25/11/2005
• Primary sponsor: Allergy Therapeutics
• Public title: Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test
• Scientific title: A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Ragweed Allergoid With MPL® With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Patients Sensitized to Ragweed Pollen.
• Date of first enrolment: November 2005
• Target sample size: 69
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00258635
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
• Affiliation: Allergy Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must be male or female aged 18-50 years, inclusive.

2. Patients must have a positive skin prick test for ragweed allergen (wheal that is =5
mm larger than the negative control).

3. Positive skin prick test to positive histamine control with a wheal (longest)
diameter =3 mm.

4. Negative skin prick test to negative control (redness, but no wheal is acceptable).

5. Specific IgE for ragweed as documented by radioallergosorbent or equivalent test with
class =2.

6. History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due
to an IgE - mediated allergy to pollen from ragweed as derived from the allergic
history.

7. Patients must score in the disease severity questionnaire as moderate or severe.

8. Males or non-pregnant, non-lactating females who are post-menopausal or naturally or
surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation
with surgery at least 6 weeks prior to study initiation).

Females of childbearing potential have a confirmed absence of pregnancy according to
a negative urine pregnancy test and must be using one of the following acceptable
birth control methods:

1. Intrauterine device in place for at least 90 days;

2. Barrier method (condom or diaphragm) with spermicide;

3. Stable hormonal contraceptive for at least 90 days prior to study and through
study completion;

4. Abstinence;

5. Non-heterosexual lifestyle;

6. Vasectomized partner for at least 90 days.

9. Patients who are normally active and otherwise judged to be in good health on the
basis of medical history, physical examination, and routine laboratory tests.

10. Patients must be willing and able to attend required study visits.

11. Patients must be able to follow instructions.

12. Patients must be willing and able to give written informed consent for this study.
Consent must be obtained prior to initiation of any washout period.

13. Spirometry at Screening demonstrates FEV1 = 80% predicted and FEV1/FVC =70%, when
applicable

Exclusion Criteria:

1. Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to
physical or chemical influence and/or chronic dermatitis.

2. Patient has moderate to severe asthma.

3. Visual inspection of the forearms indicates potential problems with the conduct or
interpretation of the skin prick test; both forearms must be available for testing.

4. History or presence of diabetes (insulin dependent and non-dependent), cancer or any
clinically significant cardiac, metabolic renal, hematologic diseases or disorders.

5. Recent clinically significant history (within 2 years) of hepatic gastrointestinal,
dermatologic, venereal, neurologic or psychiatric diseases or disorders.

6. Any clinically significant (as determined by the Investigator) abnormal laboratory
value at Visit 1.

7. Clinically relevant sensitivity against perennial allergens [house dust mites
(Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium
cladosporioides, Alternaria alternata, Penicillium chrysogenum, Aspergillus
fumigatus), cat epithelia (Felis domesticus), dog epithelia (Canis familiaris) and
horse epithelia (Equus caballus)], documented by a positive case history, prick test
wheal size =3 mm in diameter larger than the negative control or radioallergosorbent
test with class =2. Exceptions: The Investigator may judge the sensitivity as not
clinically relevant.

8. Clinically relevant sensitivity against seasonal allergens [mountain cedar, ash,
birch, elm, maple, hickory, oak, cottonwood, bermuda grass and grass mix] documented
by a positive case history, prick test wheal size =3 mm in diameter larger than the
negative control or radioallergosorbent test with class =2. Exceptions: some or all
of the listed allergens must not be tested if they are not common to the
Investigator´s region or, if common to the region, no overlap exists between the
allergen(s) season and the treatment and post treatment phase of the study.
Furthermore, subjects will not be excluded if the Investigator may judge the
sensitivity as not clinically relevant.

9. Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis).

10. History of autoimmune diseases (e.g. of liver, kidney, thyroid, nervous system),
and/or rheumatoid diseases.

11. Patient is taking ß-blockers for any indication including eye drops.

12. Patient who is not allowed to receive adrenalin.

13. Patients in whom tyrosine metabolism is disturbed, especially in the case of
tyrosinemia and alkaptonuria.

14. Presence of a disease with a pathogenesis interfering with the immune response and
patient has received medication which could influence the results of this study.

15. Documented evidence of acute or significant chronic infection.

16. History of anaphylaxis, including anaphylactic food allergy, insect venom
anaphylaxis, exercise or drug induced anaphylaxis.

17. Documented history of angioedema.

18. Hypersensitivity to excipients in the study medications.

19. Previous or current immunotherapy with comparable ragweed allergen extracts.

20. Currently using anti-allergy medication and other drugs with antihistaminic activity.

21. Patients currently participating in a clinical trial or who have been exposed to
study medication within the last 30 days.

22. Patients who cannot communicate reliably with the Investigator or who are not likely
to cooperate with the requirements of the study.

23. Patient is pregnant or planning pregnancy and/or lactating.

24. Patient has received treatment with preparation containing MPL® during the past 12
months.

25. Concurrent use of any prohibited medication(s),or inadequate washout of any
medication.

26. Any systemic disorder that could interfere with the evaluation of the study
medication(s).

27. Clinical history (within 2 years) of drug or alcohol abuse that would, in the opinion
of the Investigator, interfere with the patient's participation in the study.

28. Patient who has a positive urine drug screen (cocaine metabolites, cannabinoids,
opiates, PCP, or amphetamine), or a positive alcohol saliva test.

29. Study site staff or immediate relatives of study site staff or other individuals who
would have access to the clinical study protocol.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type I Hypersensitivity

Intervention(s)

Biological: RagweedMATAMPL

Primary Outcome(s)

To assess immunological differences between three Ragweed MATA MPL treatment arms compared to placebo with respect to immunoglobulin levels (ragweed spec. IgG, IgG1, IgG4,IgE). [Time Frame: 9 weeks]

Secondary Outcome(s)

Clinical chemistry, hematology and urinalysis; [Time Frame: 9 weeks]

Number of Adverse Events (AEs); [Time Frame: 9 weeks]

Number of Adverse Reactions; [Time Frame: 9 weeks]

Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test; [Time Frame: 20 minutes and 6 hours after skin prick test]

Tolerability of different subcutaneous doses; [Time Frame: 9 weeks]

Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test; [Time Frame: 20 minutes and 6 hours after skin prick test]

Tolerability of the cumulative subcutaneous doses; [Time Frame: 9 weeks]

Secondary ID(s)

RagweedMATAMPL203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors