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Type I HypersensitivityPhase 2NCT00258635

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

A Phase 2 study testing RagweedMATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 4 sites in United States.

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

The purpose of this study is to assess the immunological differences between three RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels. In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen contained in RagweedMATAMPL compared to unmodified native… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Type I Hypersensitivity
What is being tested?
RagweedMATAMPL
How many people
69 participants
Where
4 sitesUnited States
Study dates
Nov 2005to 7 Aug 2006
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients must be male or female aged 18-50 years, inclusive.
  • Patients must have a positive skin prick test for ragweed allergen (wheal that is ≥5 mm larger than the negative control).
  • Positive skin prick test to positive histamine control with a wheal (longest) diameter ≥3 mm.
  • Negative skin prick test to negative control (redness, but no wheal is acceptable).
  • Specific IgE for ragweed as documented by radioallergosorbent or equivalent test with class ≥2.
  • 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.
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  • Patients must score in the disease severity questionnaire as moderate or severe.
  • 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:
  • Intrauterine device in place for at least 90 days;
  • Barrier method (condom or diaphragm) with spermicide;
  • Stable hormonal contraceptive for at least 90 days prior to study and through study completion;
  • Abstinence;
  • Non-heterosexual lifestyle;
  • Vasectomized partner for at least 90 days.
  • 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.
  • Patients must be willing and able to attend required study visits.
  • Patients must be able to follow instructions.
  • 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.
  • Spirometry at Screening demonstrates FEV1 ≥ 80% predicted and FEV1/FVC ≥70%, when applicable

Who cannot join

  • Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis.
  • Patient has moderate to severe asthma.
  • 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.
  • History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders.
  • Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders.
  • Any clinically significant (as determined by the Investigator) abnormal laboratory value at Visit 1.
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  • 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.
  • 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.
  • Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis).
  • History of autoimmune diseases (e.g. of liver, kidney, thyroid, nervous system), and/or rheumatoid diseases.
  • Patient is taking ß-blockers for any indication including eye drops.
  • Patient who is not allowed to receive adrenalin.
  • Patients in whom tyrosine metabolism is disturbed, especially in the case of tyrosinemia and alkaptonuria.
  • 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.
  • Documented evidence of acute or significant chronic infection.
  • History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
  • Documented history of angioedema.
  • Hypersensitivity to excipients in the study medications.
  • Previous or current immunotherapy with comparable ragweed allergen extracts.
  • Currently using anti-allergy medication and other drugs with antihistaminic activity.
  • Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days.
  • Patients who cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study.
  • Patient is pregnant or planning pregnancy and/or lactating.
  • Patient has received treatment with preparation containing MPL® during the past 12 months.
  • Concurrent use of any prohibited medication(s),or inadequate washout of any medication.
  • Any systemic disorder that could interfere with the evaluation of the study medication(s).
  • 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.
  • Patient who has a positive urine drug screen (cocaine metabolites, cannabinoids, opiates, PCP, or amphetamine), or a positive alcohol saliva test.
  • Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Regional Allergy & Asthma Consultants

    Asheville, North Carolina, 28801

  • Lovelace Scientific Resources

    Austin, Texas, 78759

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Michigan Respiratory Health and Research Institute

    Novi, Michigan, 48375

Other trials in United States

About this study

Official 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.

The purpose of this study is to assess the immunological differences between three RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels.

In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.

Being tested
RagweedMATAMPL
Keywords
Allergy, Specific Immunotherapy
Medical subject headings
Hypersensitivity, Immediate, Hypersensitivity

What participants receive

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

  • RagweedMATAMPLBiological

What is being measured

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

  1. 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).

    Measured: 9 weeks

Secondary outcomes (7)

  1. Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test;

    Measured: 20 minutes and 6 hours after skin prick test

  2. Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test;

    Measured: 20 minutes and 6 hours after skin prick test

  3. Tolerability of different subcutaneous doses;

    Measured: 9 weeks

  4. Tolerability of the cumulative subcutaneous doses;

    Measured: 9 weeks

  5. Clinical chemistry, hematology and urinalysis;

    Measured: 9 weeks

  6. Number of Adverse Events (AEs);

    Measured: 9 weeks

  7. Number of Adverse Reactions;

    Measured: 9 weeks

Timeline

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

  1. First posted28 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completion7 Aug 2006
  4. Study completion7 Aug 2006

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00258635
Sponsor's protocol ID
RagweedMATAMPL203
Status last verified
Jun 2021
First submitted
25 Nov 2005
Last updated
11 Jun 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RagweedMATAMPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 4 sites in United States.

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 20 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

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). 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 NCT00258635.

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 11 Jun 2021.

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