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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003863-38 | EudraCT Number | ||
| MK-3641-002 | Other Identifier | Merck Protocol Number |
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This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH 39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis over a one-year period. It is expected that ragweed allergic participants on one of the active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and require less allergy rescue medications during ragweed pollen season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 39641 6 Amb a 1-U | Experimental | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
|
| SCH 39641 12 Amb a 1-U | Experimental | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
|
| Placebo | Placebo Comparator | Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 39641 6 Amb a 1-U | Biological | SCH 39641 6 Amb a 1-U sublingual tablets administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS) | The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The 15-day period during the ragweed season with the highest moving pollen average |
| Measure | Description | Time Frame |
|---|---|---|
| Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS | The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26507708 | Derived | Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21. | |
| 25788949 | Derived | Kim H, Waserman S, Hebert J, Blaiss M, Nelson H, Creticos P, Kaur A, Maloney J, Li Z, Nolte H. Efficacy and safety of ragweed sublingual immunotherapy in Canadian patients with allergic rhinoconjunctivitis. Allergy Asthma Clin Immunol. 2014 Nov 10;10(1):55. doi: 10.1186/1710-1492-10-55. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCH 39641 6 Amb a 1-U | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| FG001 | SCH 39641 12 Amb a 1-U |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| SCH 39641 12 Amb a 1-U | Biological | SCH 39641 12 Amb a 1-U sublingual tablets administered once daily |
|
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| Placebo | Biological | matching placebo sublingual tablets administered once daily |
|
| Approximately 5 weeks |
| Average Rhinoconjunctivitis DSS for the Peak RS | The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The 15-day period during the ragweed season with the highest moving pollen average |
| Average Rhinoconjunctivitis DSS for the Entire RS | The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | Approximately 5 weeks |
| Average Rhinoconjunctivitis DMS for the Peak RS | Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The 15-day period during the ragweed season with the highest moving pollen average |
| 24836393 | Derived | 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. |
| 23706715 | Derived | Nolte H, Hebert J, Berman G, Gawchik S, White M, Kaur A, Liu N, Lumry W, Maloney J. Randomized controlled trial of ragweed allergy immunotherapy tablet efficacy and safety in North American adults. Ann Allergy Asthma Immunol. 2013 Jun;110(6):450-456.e4. doi: 10.1016/j.anai.2013.03.013. Epub 2013 May 2. |
Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks
| FG002 | Placebo | Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SCH 39641 6 Amb a 1-U | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| BG001 | SCH 39641 12 Amb a 1-U | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| BG002 | Placebo | Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS) | The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues. | Posted | Mean | Standard Error | score on a scale | The 15-day period during the ragweed season with the highest moving pollen average |
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| Secondary | Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS | The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues. | Posted | Mean | Standard Error | score on a scale | Approximately 5 weeks |
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| Secondary | Average Rhinoconjunctivitis DSS for the Peak RS | The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues. | Posted | Mean | Standard Error | score on a scale | The 15-day period during the ragweed season with the highest moving pollen average |
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| Secondary | Average Rhinoconjunctivitis DSS for the Entire RS | The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues. | Posted | Mean | Standard Error | score on a scale | Approximately 5 weeks |
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| Secondary | Average Rhinoconjunctivitis DMS for the Peak RS | Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects. | The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues. | Posted | Mean | Standard Error | score on a scale | The 15-day period during the ragweed season with the highest moving pollen average |
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Up to 53 weeks
A total of 5 participants (2 in the SCH 39641 6 Amb a 1-U group, 1 in the SCH 39641 12 Amb a 1-U group and 2 in the Placebo group) at one site were excluded from all safety analyses due to GCP issues. Adverse events are reported for the remaining participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCH 39641 6 Amb a 1-U | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 6 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks | 2 | 188 | 124 | 188 | ||
| EG001 | SCH 39641 12 Amb a 1-U | Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks | 3 | 186 | 136 | 186 | ||
| EG002 | Placebo | Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks | 4 | 186 | 93 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic mass | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Stab wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Uterine enlargement | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Uterine prolapse | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Tongue pruritus | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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The Investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| Male |
|
| 0.0002 |
| Mean Difference (Final Values) |
| -2.24 |
| 2-Sided |
| 95 |
| -3.41 |
| -1.07 |
ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects |
| No |
| Superiority or Other |
Participants receive Ambrosia artemisiifolia allergen extract (SCH 39641 12 Amb a 1-U) rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
| OG002 | Placebo | Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
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| OG002 |
| Placebo |
Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
|
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| Placebo |
Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
|
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| Placebo |
Participants receive placebo matching ambrosia artemisiifolia allergen extract, rapidly dissolving tablets, administered once daily sublingually for approximately 52 weeks |
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