Trial Outcomes & Findings for A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067) (NCT NCT01385371)

Last Updated: 2017-03-03

Results Overview

The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1501 participants

Primary outcome timeframe

Entire GPS (expected average duration of 5 to 6 weeks)

Results posted on

2017-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	SCH 697243 Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo Participants receiving Placebo
Overall Study STARTED	752	749
Overall Study COMPLETED	603	652
Overall Study NOT COMPLETED	149	97

Reasons for withdrawal

Reasons for withdrawal
Measure	SCH 697243 Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo Participants receiving Placebo
Overall Study Adverse Event	54	19
Overall Study Lost to Follow-up	16	16
Overall Study Withdrawal by Subject	52	39
Overall Study Protocol Violation	25	21
Overall Study Administrative	2	2

Baseline Characteristics

A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCH 697243 n=752 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=749 Participants Participants receiving Placebo	Total n=1501 Participants Total of all reporting groups
Age, Continuous	32.9 years STANDARD_DEVIATION 14.5 • n=5 Participants	33.5 years STANDARD_DEVIATION 14.5 • n=7 Participants	33.2 years STANDARD_DEVIATION 14.5 • n=5 Participants
Gender Female	381 Participants n=5 Participants	333 Participants n=7 Participants	714 Participants n=5 Participants
Gender Male	371 Participants n=5 Participants	416 Participants n=7 Participants	787 Participants n=5 Participants

PRIMARY outcome

Timeframe: Entire GPS (expected average duration of 5 to 6 weeks)

Population: The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

Outcome measures

Outcome measures
Measure	SCH 697243 n=629 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=672 Participants Participants receiving Placebo
Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)	3.24 score on a scale Interval 0.0 to 24.1	4.22 score on a scale Interval 0.0 to 23.16

SECONDARY outcome

Timeframe: Entire GPS (expected average duration of 5 to 6 weeks)

Population: The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.

Outcome measures

Outcome measures
Measure	SCH 697243 n=629 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=672 Participants Participants receiving Placebo
Average Rhinoconjunctivitis DSS Over the Entire GPS	2.49 score on a scale Interval 0.0 to 18.0	3.13 score on a scale Interval 0.0 to 17.67

SECONDARY outcome

Timeframe: Peak GPS (expected average duration of 2 weeks)

Population: The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

Outcome measures

Outcome measures
Measure	SCH 697243 n=620 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=663 Participants Participants receiving Placebo
Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS	3.33 score on a scale Interval 0.0 to 30.88	4.67 score on a scale Interval 0.0 to 34.21

SECONDARY outcome

Timeframe: Peak GPS (expected average duration of 2 weeks)

Population: The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.

Outcome measures

Outcome measures
Measure	SCH 697243 n=476 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=520 Participants Participants receiving Placebo
Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS	0.93 score on a scale Interval 0.0 to 6.0	1.06 score on a scale Interval 0.0 to 4.95

SECONDARY outcome

Timeframe: Entire GPS (expected average duration of 5 to 6 weeks)

Population: The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.

Outcome measures

Outcome measures
Measure	SCH 697243 n=629 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=672 Participants Participants receiving Placebo
Average Rhinoconjunctivitis DMS Over the Entire GPS	0.88 score on a scale Standard Error 0.11	1.36 score on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Peak GPS (expected average duration of 2 weeks)

Population: The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

Outcome measures

Outcome measures
Measure	SCH 697243 n=620 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=663 Participants Participants receiving Placebo
Average Rhinoconjunctivitis DSS Over the Peak GPS	2.71 score on a scale Interval 0.0 to 18.0	3.40 score on a scale Interval 0.0 to 17.57

SECONDARY outcome

Timeframe: Peak GPS (expected average duration of 2 weeks)

Population: The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.

Outcome measures

Outcome measures
Measure	SCH 697243 n=620 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=663 Participants Participants receiving Placebo
Average Rhinoconjunctivitis DMS Over the Peak GPS	1.01 score on a scale Standard Error 0.13	1.63 score on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Peak GPS (expected average duration of 2 weeks)

Population: The FAS population consisted of all randomized participants \<12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry.

For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.

Outcome measures

Outcome measures
Measure	SCH 697243 n=13 Participants Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=12 Participants Participants receiving Placebo
Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)	0.89 score on a scale Interval 0.0 to 2.36	0.75 score on a scale Interval 0.22 to 2.98

Adverse Events

SCH 697243

Serious events: 14 serious events

Other events: 480 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 316 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	SCH 697243 n=753 participants at risk Participants receiving Grass (Phleum pratense) Pollen Allergen Extract	Placebo n=745 participants at risk Participants receiving Placebo
Ear and labyrinth disorders Ear pruritus	12.2% 92/753 • Number of events 108 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	1.6% 12/745 • Number of events 13 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Gastrointestinal disorders Lip swelling	6.1% 46/753 • Number of events 61 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	0.67% 5/745 • Number of events 5 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Gastrointestinal disorders Oedema mouth	13.0% 98/753 • Number of events 126 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	1.2% 9/745 • Number of events 10 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Gastrointestinal disorders Oral pruritus	18.5% 139/753 • Number of events 171 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	2.8% 21/745 • Number of events 24 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Gastrointestinal disorders Paraesthesia oral	12.2% 92/753 • Number of events 152 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	3.2% 24/745 • Number of events 28 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Gastrointestinal disorders Tongue pruritus	7.0% 53/753 • Number of events 66 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	0.67% 5/745 • Number of events 5 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Infections and infestations Nasopharyngitis	13.7% 103/753 • Number of events 133 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	16.4% 122/745 • Number of events 148 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Infections and infestations Upper respiratory tract infection	10.4% 78/753 • Number of events 97 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	11.5% 86/745 • Number of events 99 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Nervous system disorders Headache	8.6% 65/753 • Number of events 100 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	7.5% 56/745 • Number of events 94 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 60/753 • Number of events 73 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	5.8% 43/745 • Number of events 49 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.2% 39/753 • Number of events 41 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	3.4% 25/745 • Number of events 28 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 46/753 • Number of events 53 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	3.6% 27/745 • Number of events 37 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
Respiratory, thoracic and mediastinal disorders Throat irritation	24.0% 181/753 • Number of events 250 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.	3.9% 29/745 • Number of events 30 • Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks). The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 trial.
Publication restrictions are in place

Restriction type: OTHER