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

• ClinicalTrials.gov Identifier: NCT03570957
• Recruitment Status: Completed
• First Posted: June 27, 2018
• Last Update Posted: January 23, 2019
• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Information provided by (Responsible Party): Mitsubishi Tanabe Pharma Corporation

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Japan

Investigational Site

Tokyo, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: General Manager; Mitsubishi Tanabe Pharma Corporation

More Information

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT03570957
• Other Study ID Numbers: MT-2990-J01
• First Posted: June 27, 2018
• Last Update Posted: January 23, 2019
• Last Verified: January 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases