search
Back to results

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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MT-2990
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MT-2990, Low dose

MT-2990, Low-middle dose

MT-2990, High-middle dose

MT-2990, High dose

Placebo

Arm Description

Single intravenous dose

Single intravenous dose

Single intravenous dose

Single intravenous dose

Single intravenous dose

Outcomes

Primary Outcome Measures

Safety and tolerability as measured by incidence of adverse events
Proportion of subjects who develop antibodies against MT-2990 in serum

Secondary Outcome Measures

MT-2990 concentration in serum
Maximum observed serum concentration (Cmax) of MT-2990
Measured time of maximum observed serum concentration (tmax) of MT-2990
Apparent terminal elimination half-life (t1/2) of MT-2990
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
AUC from time zero to infinity (AUC0-∞) of MT-2990
Terminal elimination rate constant (kel) of MT-2990
Apparent volume of distribution at steady state (Vss) of MT-2990
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
Apparent serum clearance (CL) of MT-2990
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
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.
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.
Total symptom score (TSS)
TSS is TNSS plus TOSS.
Change from baseline in TNSS
Baseline is pre-exposure.
Change from baseline in TOSS
Change from baseline in TSS
Sum of TNSS during allergen exposure in EEC
Sum of TOSS during allergen exposure in EEC
Sum of TSS during allergen exposure in EEC
AUC of TNSS after allergen exposure
AUC of TOSS after allergen exposure
AUC of TSS after allergen exposure
Proportion of subjects with increased TNSS from baseline
Proportion of subjects with increased TOSS from baseline
Proportion of subjects with increased TSS from baseline

Full Information

First Posted
June 18, 2018
Last Updated
January 22, 2019
Sponsor
Mitsubishi Tanabe Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03570957
Brief Title
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
Official Title
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
December 27, 2018 (Actual)
Study Completion Date
December 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-2990, Low dose
Arm Type
Experimental
Arm Description
Single intravenous dose
Arm Title
MT-2990, Low-middle dose
Arm Type
Experimental
Arm Description
Single intravenous dose
Arm Title
MT-2990, High-middle dose
Arm Type
Experimental
Arm Description
Single intravenous dose
Arm Title
MT-2990, High dose
Arm Type
Experimental
Arm Description
Single intravenous dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single intravenous dose
Intervention Type
Drug
Intervention Name(s)
MT-2990
Intervention Description
MT-2990 solution for injection in vial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution for injection in vial
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by incidence of adverse events
Time Frame
Up to Day 113
Title
Proportion of subjects who develop antibodies against MT-2990 in serum
Time Frame
Up to Day 113
Secondary Outcome Measure Information:
Title
MT-2990 concentration in serum
Time Frame
Up to Day 113
Title
Maximum observed serum concentration (Cmax) of MT-2990
Time Frame
Up to Day 113
Title
Measured time of maximum observed serum concentration (tmax) of MT-2990
Time Frame
Up to Day 113
Title
Apparent terminal elimination half-life (t1/2) of MT-2990
Time Frame
Up to Day 113
Title
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
Time Frame
Up to Day 113
Title
AUC from time zero to infinity (AUC0-∞) of MT-2990
Time Frame
Up to Day 113
Title
Terminal elimination rate constant (kel) of MT-2990
Time Frame
Up to Day 113
Title
Apparent volume of distribution at steady state (Vss) of MT-2990
Time Frame
Up to Day 113
Title
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Time Frame
Up to Day 113
Title
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
Time Frame
Up to Day 113
Title
Apparent serum clearance (CL) of MT-2990
Time Frame
Up to Day 113
Title
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
Time Frame
Up to Day 113
Title
Total nasal symptom score (TNSS)
Description
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.
Time Frame
Day 8, 29, 57, and 85
Title
Total ocular symptom score (TOSS)
Description
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.
Time Frame
Day 8, 29, 57, and 85
Title
Total symptom score (TSS)
Description
TSS is TNSS plus TOSS.
Time Frame
Day 8, 29, 57, and 85
Title
Change from baseline in TNSS
Description
Baseline is pre-exposure.
Time Frame
Day 8, 29, 57, and 85
Title
Change from baseline in TOSS
Time Frame
Day 8, 29, 57, and 85
Title
Change from baseline in TSS
Time Frame
Day 8, 29, 57, and 85
Title
Sum of TNSS during allergen exposure in EEC
Time Frame
Day 8, 29, 57, and 85
Title
Sum of TOSS during allergen exposure in EEC
Time Frame
Day 8, 29, 57, and 85
Title
Sum of TSS during allergen exposure in EEC
Time Frame
Day 8, 29, 57, and 85
Title
AUC of TNSS after allergen exposure
Time Frame
Day 8, 29, 57, and 85
Title
AUC of TOSS after allergen exposure
Time Frame
Day 8, 29, 57, and 85
Title
AUC of TSS after allergen exposure
Time Frame
Day 8, 29, 57, and 85
Title
Proportion of subjects with increased TNSS from baseline
Time Frame
Day 8, 29, 57, and 85
Title
Proportion of subjects with increased TOSS from baseline
Time Frame
Day 8, 29, 57, and 85
Title
Proportion of subjects with increased TSS from baseline
Time Frame
Day 8, 29, 57, and 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs