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

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: MT-2990; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-2990, Low dose; Single intravenous dose	Drug: MT-2990; MT-2990 solution for injection in vial; Drug: Placebo; Placebo solution for injection in vial
Experimental: MT-2990, Low-middle dose; Single intravenous dose	Drug: MT-2990; MT-2990 solution for injection in vial; Drug: Placebo; Placebo solution for injection in vial
Experimental: MT-2990, High-middle dose; Single intravenous dose	Drug: MT-2990; MT-2990 solution for injection in vial; Drug: Placebo; Placebo solution for injection in vial
Experimental: MT-2990, High dose; Single intravenous dose	Drug: MT-2990; MT-2990 solution for injection in vial
Placebo Comparator: Placebo; Single intravenous dose	Drug: Placebo; Placebo solution for injection in vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
MT-2990 concentration in serum		Up to Day 113
Maximum observed serum concentration (Cmax) of MT-2990		Up to Day 113
Measured time of maximum observed serum concentration (tmax) of MT-2990		Up to Day 113
Apparent terminal elimination half-life (t1/2) 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
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
Apparent volume of distribution during terminal phase after IV administration (Vz) 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
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990		Up to Day 113
Total nasal symptom score (TNSS)	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.	Day 8, 29, 57, and 85
Total ocular symptom score (TOSS)	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.	Day 8, 29, 57, and 85
Total symptom score (TSS)	TSS is TNSS plus TOSS.	Day 8, 29, 57, and 85
Change from baseline in TNSS	Baseline is pre-exposure.	Day 8, 29, 57, and 85
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
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
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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): December 27, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: MT-2990-J01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No