Chronic Spontaneous Urticaria
Conditions
Brief summary
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.
Interventions
DRUGMTPS9579A
MTPS9579A will be administered.
DRUGPlacebo
Placebo matched with MTPS9579A will be administered.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the UAS7 | Week 12 | Change from baseline in the Urticaria Activity Score summed over 7 days (UAS7) at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Achieve Complete Response | Week 12 | Proportion of participants who achieve complete response (UAS7=0) at Week 12. |
| Percentage of Participants With Adverse Events | Up to approximately 96 weeks | Percentage of participants with adverse events. |
| Proportion of Participants With Well-Controlled Urticaria | Week 12 | Proportion of participants with well-controlled urticaria (UAS7\<=6) at Week 12. |
| Prevalence of Anti-Drug Antibodies (ADAs) | Through Week 20 | — |
| Incidence of ADAs | Through Week 20 | — |
| Serum Concentration of MTPS9579A | Through Week 20 | — |
Outcome results
None listed