A Phase 3 interventional study of MK-8237 tablets and Placebo tablets in Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Nonseasonal, sponsored by ALK-Abelló A/S. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.
The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 1,482 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).
Biological: MK-8237 tablets · Drug: Rescue Medication: Self-Injectable Epinephrine · Drug: Rescue Medication: Loratadine tablets · Drug: Rescue Medication: Olopatadine ophthalmic drops · Drug: Rescue Medication: Mometasone furoate nasal spray
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Biological: Placebo tablets · Drug: Rescue Medication: Self-Injectable Epinephrine · Drug: Rescue Medication: Loratadine tablets · Drug: Rescue Medication: Olopatadine ophthalmic drops · Drug: Rescue Medication: Mometasone furoate nasal spray
MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
Also known as: SCH 900237
Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
Loratadine tablet 10 mg administered orally as needed for rescue medication.
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 54 weeks
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 52 weeks
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
Time frame: Last 8 weeks of treatment (Weeks 44 to 52)
| Milestone | MK-8237 | Placebo |
|---|---|---|
| Started | 741 | 741 |
| Treated | 740 | 741 |
| All participants as treated (apat) | 743 | 738 |
| Completed | 561 | 613 |
| Not completed | 180 | 128 |
| Withdrew: Adverse event | 73 | 18 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Lost to follow-up | 42 | 29 |
| Withdrew: Noncompliance with study drug | 0 | 5 |
| Withdrew: Physician decision | 2 | 3 |
| Withdrew: Pregnancy | 1 | 4 |
| Withdrew: Progressive disease | 1 | 0 |
| Withdrew: Protocol violation | 3 | 4 |
| Withdrew: Technical problems | 0 | 1 |
| Withdrew: Withdrawal by subject | 56 | 64 |
| Withdrew: Never received study drug | 1 | 0 |
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
| Score on a Scale | MK-8237 | Placebo |
|---|---|---|
| Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | 4.67 ± 3.55 | 5.49 ± 3.82 |
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Participants | MK-8237 | Placebo |
|---|---|---|
| Number of Participants Who Experience At Least One Adverse Event (AE) | 676 | 539 |
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Participants | MK-8237 | Placebo |
|---|---|---|
| Number of Participants Who Discontinue Study Drug Due to an AE | 73 | 19 |
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
| Score on a Scale | MK-8237 | Placebo |
|---|---|---|
| Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | 3.83 ± 2.64 | 4.46 ± 2.80 |
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
| Score on a Scale | MK-8237 | Placebo |
|---|---|---|
| Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | 0.84 ± 1.817 | 1.03 ± 2.074 |
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
| Score on a Scale | MK-8237 | Placebo |
|---|---|---|
| Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment | 6.40 ± 5.16 | 7.62 ± 5.48 |
Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
| Score on a Scale | MK-8237 | Placebo |
|---|---|---|
| Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment | 42.29 ± 23.57 | 47.96 ± 23.66 |
Collected over Up to 54 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-8237 12 DU | — | 11/743 (1.5%) | 642/743 (86.4%) |
| Placebo | — | 7/738 (0.9%) | 389/738 (52.7%) |
| Event | MK-8237 12 DU | Placebo |
|---|---|---|
| Small intestinal obstructionGastrointestinal disorders | 0/743 | 1/738 |
| CholelithiasisHepatobiliary disorders | 0/743 | 1/738 |
| Anaphylactic reactionImmune system disorders | 0/743 | 1/738 |
| Food allergyImmune system disorders | 0/743 | 1/738 |
| Hepatic cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/743 | 1/738 |
| Bipolar I disorderPsychiatric disorders | 0/743 | 1/738 |
| DepressionPsychiatric disorders | 0/743 | 1/738 |
| PericarditisCardiac disorders | 1/743 | 0/738 |
| Tympanic membrane perforationEar and labyrinth disorders | 1/743 | 0/738 |
| Oral painGastrointestinal disorders | 1/743 | 0/738 |
| Event | MK-8237 12 DU | Placebo |
|---|---|---|
| Throat irritationRespiratory, thoracic and mediastinal disorders | 506/743 | 172/738 |
| Oral pruritusGastrointestinal disorders | 468/743 | 109/738 |
| Ear pruritusEar and labyrinth disorders | 382/743 | 92/738 |
| Lip swellingGastrointestinal disorders | 140/743 | 19/738 |
| Swollen tongueGastrointestinal disorders | 123/743 | 17/738 |
| NauseaGastrointestinal disorders | 121/743 | 57/738 |
| GlossodyniaGastrointestinal disorders | 119/743 | 26/738 |
| Pharyngeal oedemaRespiratory, thoracic and mediastinal disorders | 109/743 | 23/738 |
| Tongue ulcerationGastrointestinal disorders | 96/743 | 21/738 |
| Abdominal pain upperGastrointestinal disorders | 92/743 | 44/738 |
Baseline Characteristics refer to all randomized participants.
| Age, Continuous(Years) | MK-8237 | Placebo | Total |
|---|---|---|---|
| Mean | 34.9 ± 13.82 | 35.2 ± 13.74 | 35.1 ± 13.77 |
| Sex: Female, Male(Participants) | MK-8237 | Placebo | Total |
|---|---|---|---|
| Female | 445 | 430 | 875 |
| Male | 296 | 311 | 607 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ALK-Abelló A/S