A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Phase 1

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: MT-2990; Drug: Placebo

• Registration Number: NCT03570957
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-27
• Study Start: 2018-07-17
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• A body weight of 40 to 100 kg for female or 45 to 100 kg for male
• A body mass index of 18 to 30 kg/m2
• Subjects who have current history of JC-SAR in previous 2 consecutive years.
• Presence (CAP-RAST: ≥2) of IgE specific to Japanese cedar pollens and absence (CAP-RAST: ≤1) of IgE specific to other 4 allergens
• Presence of at least 2 symptoms, which are moderate to very severe, in 4 nasal symptoms (runny nose, sneezing, blocked nose, itchy nose) at any time point during allergen exposure in EEC at screening period

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Exclusion Criteria

• Presence of any symptoms of allergic rhinitis within 1 year except scattering season of cedar pollen or cypress pollen
• Subjects who have persistent symptom caused by allergen exposure in EEC at screening period until Day 1 (pre-dose)
• Underwent nasal surgery (include laser surgery) to improve nasal symptoms within 2 years
• Underwent specific immunotherapy or non-specific immunotherapy within 5 years
• Underwent medication of anti-histamine, oral mast cell stabilizer, leukotriene receptor antagonist, prostaglandin D2/thromboxane A2 receptor antagonist, Th2 cytokine inhibitor, corticosteroid (oral form, intra-nasal form, ocular form), or vasoconstrictor within 4 weeks
• Underwent medication of corticosteroid (injection form) or anti-IgE antibody within 6 months
• Subject who is concerned about exacerbation of the physical condition due to allergen exposure in EEC

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-2990, Low-middle dose	Placebo	Single intravenous dose
MT-2990, Low dose	MT-2990	Single intravenous dose
MT-2990, Low dose	Placebo	Single intravenous dose
MT-2990, Low-middle dose	MT-2990	Single intravenous dose
MT-2990, High-middle dose	MT-2990	Single intravenous dose
MT-2990, High-middle dose	Placebo	Single intravenous dose
MT-2990, High dose	MT-2990	Single intravenous dose
Placebo	Placebo	Single intravenous dose

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by incidence of adverse events	Up to Day 113
Proportion of subjects who develop antibodies against MT-2990 in serum	Up to Day 113

Secondary Outcome Measures

Name	Time	Method
MT-2990 concentration in serum	Up to Day 113
Sum of TSS during allergen exposure in EEC	Day 8, 29, 57, and 85
AUC of TNSS after allergen exposure	Day 8, 29, 57, and 85
Apparent terminal elimination half-life (t1/2) of MT-2990	Up to Day 113
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990	Up to Day 113
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990	Up to Day 113
AUC from time zero to infinity (AUC0-∞) of MT-2990	Up to Day 113
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990	Up to Day 113
Apparent serum clearance (CL) of MT-2990	Up to Day 113
AUC of TOSS after allergen exposure	Day 8, 29, 57, and 85
AUC of TSS after allergen exposure	Day 8, 29, 57, and 85
Proportion of subjects with increased TNSS from baseline	Day 8, 29, 57, and 85
Proportion of subjects with increased TOSS from baseline	Day 8, 29, 57, and 85
Proportion of subjects with increased TSS from baseline	Day 8, 29, 57, and 85
Measured time of maximum observed serum concentration (tmax) of MT-2990	Up to Day 113
Terminal elimination rate constant (kel) of MT-2990	Up to Day 113
Apparent volume of distribution at steady state (Vss) of MT-2990	Up to Day 113
Change from baseline in TNSS	Day 8, 29, 57, and 85	Baseline is pre-exposure.
Change from baseline in TOSS	Day 8, 29, 57, and 85
Change from baseline in TSS	Day 8, 29, 57, and 85
Sum of TNSS during allergen exposure in EEC	Day 8, 29, 57, and 85
Sum of TOSS during allergen exposure in EEC	Day 8, 29, 57, and 85
Maximum observed serum concentration (Cmax) of MT-2990	Up to Day 113
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990	Up to Day 113
Total nasal symptom score (TNSS)	Day 8, 29, 57, and 85	Four nasal symptoms (runny nose, sneezing, blocked nose, and itchy nose) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TNSS is sum of 4 nasal symptoms, score range is 0 to 16.
Total ocular symptom score (TOSS)	Day 8, 29, 57, and 85	Two ocular symptoms (itchy eyes and watery eyes) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TOSS is sum of 2 ocular symptoms, score range is 0 to 8.
Total symptom score (TSS)	Day 8, 29, 57, and 85	TSS is TNSS plus TOSS.

Trial Locations

Locations (1)

Investigational Site; 🇯🇵 Tokyo, Japan