A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Study Overview
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Brief Summary
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This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.

Official Title
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A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot and Dose-Ranging Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

Conditions
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Chronic Spontaneous Urticaria

Intervention / Treatment
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* Drug: MTPS9579A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of CSU refractory to sgH1-AHs at the time of randomization Demonstrated ability to comply with the required use of the eDiary for the duration of the study For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at a stable dose for >=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: Previous participation in a clinical trial of MTPS9579A Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema Other skin disease associated with chronic itching Uncontrolled disease where flares are commonly treated with systemic corticosteroids History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study History of anaphylaxis without clearly identifiable avoidable antigen History of anaphylaxis to any biologic therapy for any indication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: MTPS9579A Dose A<br>In Part 1, participants will receive MTPS9579A dose A every 4 weeks from randomization to Week 12. | Drug: MTPS9579A<br>* MTPS9579A will be administered.<br>|
| Placebo Comparator: Part 1: Placebo<br>In Part 1, participants will receive placebo matched with MTPS9579A, every 4 weeks from randomization through Week 12. | Drug: Placebo<br>* Placebo matched with MTPS9579A will be administered.<br>|
| Experimental: Part 2: MTPS9579A Dose A<br>In Part 2, participants will receive MTPS9579A dose A, every 4 weeks from randomization to Week 12. | Drug: MTPS9579A<br>* MTPS9579A will be administered.<br>|
| Experimental: Part 2: MTPS9579A Dose B<br>In Part 2, participants will receive MTPS9579A dose B, every 4 weeks from randomization to Week 12. | Drug: MTPS9579A<br>* MTPS9579A will be administered.<br>|
| Experimental: Part 2: MTPS9579A Dose C<br>In Part 2, participants will receive MTPS9579A dose C, every 4 weeks from randomization to Week 12. | Drug: MTPS9579A<br>* MTPS9579A will be administered.<br>|
| Experimental: Part 2: MTPS9579A Dose D<br>In Part 2, participants will receive MTPS9579A dose D, every 4 weeks from randomization to Week 12. | Drug: MTPS9579A<br>* MTPS9579A will be administered.<br>|
| Placebo Comparator: Part 2: Placebo Dose A<br>In Part 2, participants will receive placebo matched with MTPS9579A dose A and B, every 4 weeks from randomization through Week 12. | Drug: Placebo<br>* Placebo matched with MTPS9579A will be administered.<br>|
| Placebo Comparator: Part 2: Placebo Dose B<br>In Part 2, participants will receive placebo matched with MTPS9579A dose C and D, every 4 weeks from randomization through Week 12. | Drug: Placebo<br>* Placebo matched with MTPS9579A will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the UAS7 | Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Well-Controlled Urticaria | Proportion of participants with well-controlled urticaria (UAS7<=6) at Week 12. | Week 12 | 
| Proportion of Participants Who Achieve Complete Response | Proportion of participants who achieve complete response (UAS7=0) at Week 12. | Week 12 | 
| Percentage of Participants With Adverse Events | Percentage of participants with adverse events. | Up to approximately 96 weeks | 
| Serum Concentration of MTPS9579A |  | Through Week 20 | 
| Prevalence of Anti-Drug Antibodies (ADAs) |  | Through Week 20 | 
| Incidence of ADAs |  | Through Week 20 |