Trial Outcomes & Findings for A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751) (NCT NCT01469182)

NCT ID: NCT01469182

Last Updated: 2017-03-03

Results Overview

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 914 participants
• Primary outcome timeframe: Up to Day 35
• Results posted on: 2017-03-03

Participant Flow

Participant milestones

Measure	SCH 39641 12 Amb a 1-U 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.	Placebo Matching placebo tablet, sublingual, once daily.
Overall Study STARTED	610	304
Overall Study Treated	609	304
Overall Study COMPLETED	575	298
Overall Study NOT COMPLETED	35	6

Reasons for withdrawal

Measure	SCH 39641 12 Amb a 1-U 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.	Placebo Matching placebo tablet, sublingual, once daily.
Overall Study Adverse Event	21	3
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	4	1
Overall Study Protocol Violation	4	2
Overall Study Did not meet Protocol Eligibility	3	0

Baseline Characteristics

A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

Baseline characteristics by cohort

Measure	SCH 39641 12 Amb a 1-U n=610 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.	Total n=914 Participants Total of all reporting groups
Age, Continuous	40.7 Years STANDARD_DEVIATION 12.6 • n=93 Participants	42.3 Years STANDARD_DEVIATION 12.2 • n=4 Participants	41.2 Years STANDARD_DEVIATION 12.5 • n=27 Participants
Gender Female	345 Participants n=93 Participants	177 Participants n=4 Participants	522 Participants n=27 Participants
Gender Male	265 Participants n=93 Participants	127 Participants n=4 Participants	392 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Day 35

Population: All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number 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.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants With Treatment-emergent Adverse Events (AEs)	321 Participants	130 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Oral Pruritus.	44 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Ear Pruritus	52 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Throat Irritation	82 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Mouth Oedema	34 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Eye Pruritus	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Nasal Passage Irritation	21 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to Day 35

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Reporting Skin Pruritus	18 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: ASAT consisting of participants who received at least one dose of study treatment

Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to 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.

Outcome measures

Measure	SCH 39641 12 Amb a 1-U n=609 Participants 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 Participants Matching placebo tablet, sublingual, once daily.
Number of Participants Who Discontinued Due to Treatment-emergent AEs	21 Participants	3 Participants

Adverse Events

SCH 39641 12 Amb a 1-U

Serious events: 1 serious events

Other events: 199 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	SCH 39641 12 Amb a 1-U n=609 participants at risk 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 participants at risk Matching placebo tablet, sublingual, once daily.
Blood and lymphatic system disorders Haemorrhagic anemia	0.16% 1/609 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.00% 0/304 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/609 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Immune system disorders Anaphylactic reaction	0.00% 0/609 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Infections and infestations Arthritis bacterial	0.00% 0/609 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Injury, poisoning and procedural complications Ankle fracture	0.16% 1/609 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.00% 0/304 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Injury, poisoning and procedural complications Fibula fracture	0.16% 1/609 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.00% 0/304 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Injury, poisoning and procedural complications Tibia fracture	0.16% 1/609 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.00% 0/304 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.00% 0/609 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Vascular disorders Thrombophlebitis superficial	0.00% 0/609 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.

Other adverse events

Measure	SCH 39641 12 Amb a 1-U n=609 participants at risk 12 Amb a 1-U extract in an AIT, sublingual, once daily.	Placebo n=304 participants at risk Matching placebo tablet, sublingual, once daily.
Ear and labyrinth disorders Ear pruritus	8.5% 52/609 • Number of events 62 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.66% 2/304 • Number of events 2 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Gastrointestinal disorders Oedema mouth	5.6% 34/609 • Number of events 39 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	0.33% 1/304 • Number of events 1 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Gastrointestinal disorders Oral pruritus	7.2% 44/609 • Number of events 50 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	1.6% 5/304 • Number of events 5 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Gastrointestinal disorders Paraesthesia oral	11.5% 70/609 • Number of events 106 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	5.3% 16/304 • Number of events 24 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Infections and infestations Nasopharyngitis	4.1% 25/609 • Number of events 26 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	5.3% 16/304 • Number of events 16 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Nervous system disorders Headache	5.3% 32/609 • Number of events 38 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	5.6% 17/304 • Number of events 19 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
Respiratory, thoracic and mediastinal disorders Throat irritation	13.3% 81/609 • Number of events 105 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.	3.3% 10/304 • Number of events 11 • Up to Day 35 ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor for review 45 days prior to submission for publication or presentation copies of abstracts or manuscripts that report any results of the trial. If the parties disagree concerning the sponsor's confidential information the investigator agrees to meet with the sponsor's representative, prior to submission for publication, to discuss and resolve any issues or disagreement.
• Publication restrictions are in place

Restriction type: OTHER