Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MT-2990-J01
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03570957
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: MT-2990 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : December 27, 2018
Actual Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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




Primary Outcome Measures :
  1. Safety and tolerability as measured by incidence of adverse events [ Time Frame: Up to Day 113 ]
  2. Proportion of subjects who develop antibodies against MT-2990 in serum [ Time Frame: Up to Day 113 ]

Secondary Outcome Measures :
  1. MT-2990 concentration in serum [ Time Frame: Up to Day 113 ]
  2. Maximum observed serum concentration (Cmax) of MT-2990 [ Time Frame: Up to Day 113 ]
  3. Measured time of maximum observed serum concentration (tmax) of MT-2990 [ Time Frame: Up to Day 113 ]
  4. Apparent terminal elimination half-life (t1/2) of MT-2990 [ Time Frame: Up to Day 113 ]
  5. AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990 [ Time Frame: Up to Day 113 ]
  6. AUC from time zero to infinity (AUC0-∞) of MT-2990 [ Time Frame: Up to Day 113 ]
  7. Terminal elimination rate constant (kel) of MT-2990 [ Time Frame: Up to Day 113 ]
  8. Apparent volume of distribution at steady state (Vss) of MT-2990 [ Time Frame: Up to Day 113 ]
  9. Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990 [ Time Frame: Up to Day 113 ]
  10. Mean residence time from time zero to infinity (MRT0-∞) of MT-2990 [ Time Frame: Up to Day 113 ]
  11. Apparent serum clearance (CL) of MT-2990 [ Time Frame: Up to Day 113 ]
  12. Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990 [ Time Frame: Up to Day 113 ]
  13. Total nasal symptom score (TNSS) [ Time Frame: 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.

  14. Total ocular symptom score (TOSS) [ Time Frame: 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.

  15. Total symptom score (TSS) [ Time Frame: Day 8, 29, 57, and 85 ]
    TSS is TNSS plus TOSS.

  16. Change from baseline in TNSS [ Time Frame: Day 8, 29, 57, and 85 ]
    Baseline is pre-exposure.

  17. Change from baseline in TOSS [ Time Frame: Day 8, 29, 57, and 85 ]
  18. Change from baseline in TSS [ Time Frame: Day 8, 29, 57, and 85 ]
  19. Sum of TNSS during allergen exposure in EEC [ Time Frame: Day 8, 29, 57, and 85 ]
  20. Sum of TOSS during allergen exposure in EEC [ Time Frame: Day 8, 29, 57, and 85 ]
  21. Sum of TSS during allergen exposure in EEC [ Time Frame: Day 8, 29, 57, and 85 ]
  22. AUC of TNSS after allergen exposure [ Time Frame: Day 8, 29, 57, and 85 ]
  23. AUC of TOSS after allergen exposure [ Time Frame: Day 8, 29, 57, and 85 ]
  24. AUC of TSS after allergen exposure [ Time Frame: Day 8, 29, 57, and 85 ]
  25. Proportion of subjects with increased TNSS from baseline [ Time Frame: Day 8, 29, 57, and 85 ]
  26. Proportion of subjects with increased TOSS from baseline [ Time Frame: Day 8, 29, 57, and 85 ]
  27. Proportion of subjects with increased TSS from baseline [ Time Frame: Day 8, 29, 57, and 85 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570957


Locations
Layout table for location information
Japan
Investigational Site
Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Layout table for investigator information
Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03570957     History of Changes
Other Study ID Numbers: MT-2990-J01
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases