RhinoconjunctivitisPhase 2NCT00978029

Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

A Phase 2 study testing SCH 39641 in people with Rhinoconjunctivitis and Rhinitis, run by ALK-Abelló A/S.

Completed

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

Trial summary

The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Rhinoconjunctivitis, Rhinitis, Conjunctivitis
What is being tested?: SCH 39641
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 203 participants
Where: No sites listed yet
Study dates: Nov 2009to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Who cannot join

Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
Subject requiring anti-allergy medications during the time period from randomization to study completion.
Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
Subject with a history of anaphylaxis with cardiorespiratory symptoms.
Subject with a history of chronic urticaria or angioedema.
Subject with current severe atopic dermatitis.

Show all 9Show fewer

Female subject who is breastfeeding, pregnant, or intending to become pregnant.
Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
Subject with a history of self-injectable epinephrine use.

About this study

Official title: A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)

Conditions: Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
Being tested: Placebo, SCH 39641
Keywords: immunotherapy
Medical subject headings: Rhinitis, Conjunctivitis, Hypersensitivity

What participants receive

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

PlaceboDrug
Placebo sublingual tablet, once daily
SCH 39641Biological
Also called MK-3641
Allergy immunotherapy tablet (sublingual)
SCH 39641Biological
Also called MK-3641
Allergy immunotherapy tablet (sublingual)

Study groups in NCT00978029
Study group	Role	What they receive
Placebo	Placebo comparator	Matching placebo tablet sublingual, once daily Receives: Drug: Placebo
SCH 39641 6 Amb a 1-U	Experimental	6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily Receives: Biological: SCH 39641
SCH 39641 12 Amb a 1-U	Experimental	12 Amb a 1-U in an AIT, sublingual, once daily Receives: Biological: SCH 39641

What is being measured

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

The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
Measured: Up to Day 42

Secondary outcomes (5)

Proportion of Participants Reporting Oral Pruritus
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.
Measured: Up to Day 42
Proportion of Participants Reporting Ear Pruritus
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.
Measured: Up to Day 42
Proportion of Participants Reporting Throat Irritation
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.
Measured: Up to Day 42
Proportion of Participants Reporting Mouth Oedema
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.
Measured: Up to Day 42
Proportion of Participants Who Discontinued Due to Adverse Events.
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Day 28

Timeline

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

Nov 2009Feb 2010

First posted16 Sep 2009 (estimated)
Study startNov 2009
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00978029
Sponsor's protocol ID: P06081
Other IDs: MK-3641-004
Status last verified: Jan 2017
First submitted: 11 Sep 2009
Last updated: 3 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.
PubMed 24836393

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis

All Rhinoconjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)
ClinicalTrials.gov ID: NCT00978029
Acronym / sponsor ID: P06081
Conditions: Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
Keywords: immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: ALK-Abelló A/SIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 16 Sep 2009 (estimated)
Results: Posted 23 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMatching placebo tablet sublingual, once daily
SCH 39641 6 Amb a 1-U	Experimental	Biological: SCH 396416 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily
SCH 39641 12 Amb a 1-U	Experimental	Biological: SCH 3964112 Amb a 1-U in an AIT, sublingual, once daily

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Key exclusion criteria (9 listed)

Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
Subject requiring anti-allergy medications during the time period from randomization to study completion.
Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
Subject with a history of anaphylaxis with cardiorespiratory symptoms.
Subject with a history of chronic urticaria or angioedema.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo sublingual tablet, once daily	Drug	Placebo
SCH 39641Also: MK-3641Allergy immunotherapy tablet (sublingual)	Biological	SCH 39641 6 Amb a 1-U
SCH 39641Also: MK-3641Allergy immunotherapy tablet (sublingual)	Biological	SCH 39641 12 Amb a 1-U

Primary outcome

The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)
Time frame: Up to Day 42
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.

5 secondary outcomes

Proportion of Participants Reporting Oral Pruritus
Time frame: Up to Day 42
Proportion of Participants Reporting Ear Pruritus
Time frame: Up to Day 42
Proportion of Participants Reporting Throat Irritation
Time frame: Up to Day 42
Proportion of Participants Reporting Mouth Oedema
Time frame: Up to Day 42
Proportion of Participants Who Discontinued Due to Adverse Events.
Time frame: Up to Day 28

Results and safety

Results posted to the registry on 23 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	65	64
SCH 39641 6 Amb a 1-U	66	63
SCH 39641 12 Amb a 1-U	65	59

Primary outcome: The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)

Time frame: Up to Day 42. Number. Unit: Proportion of Participants

Measure	Placebo n = 65	SCH 39641 6 Amb a 1-U n = 66	SCH 39641 12 Amb a 1-U n = 65
Value	0.446	0.515	0.615

Placebo vs SCH 39641 6 Amb a 1-U: Percent Difference: 6.9 (95% CI -10.17 to 23.97), p = 0.486, Fisher Exact
Placebo vs SCH 39641 12 Amb a 1-U: Percent Difference: 16.9 (95% CI 0.01 to 33.83), p = 0.078, Fisher Exact

Population analysed: All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 42. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 65 (0%)	11 of 65 (16.9%)	Not reported
SCH 39641 6 Amb a 1-U	0 of 66 (0%)	23 of 66 (34.8%)	Not reported
SCH 39641 12 Amb a 1-U	1 of 65 (1.5%)	23 of 65 (35.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24836393Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

Related trials for Rhinoconjunctivitis

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCH 39641 in people with Rhinoconjunctivitis and Rhinitis, run by ALK-Abelló A/S.

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 5 inclusion and 9 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) (time frame: Up to Day 42). 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 NCT00978029, which also lists 1 linked publication.

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 3 Mar 2017.