Refractory Chronic Spontaneous Urticaria
Conditions
Interventions
Product Name: MTPS9579A
Product Code: RO7198434
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: RO7198434
Other descriptive name: RO71
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-75 years • Body mass index (BMI) of 18-38 kg/m^2 and weight >=40 kg at screening • Diagnosis of CSU refractory to second-generation H1 antihistamine (sgH1-AHs) at the time of randomization • Demonstrated compliance with required use of the Urticaria eDiary • For patients on H2 antihistamines or leukotriene receptor antagonists (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 • Use of contraceptive measures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Previous participation in a clinical trial of MTPS9579A • Chronic urticaria with known cause or other diseases with symptoms of urticaria or angioedema • 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, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MTPS9579A compared with placebo based on change from baseline in the Urticaria Activity Score summed over 7 days (UAS7);Secondary Objective: •To evaluate the efficacy of MTPS9579A compared with placebo based on proportion of patients with well-controlled urticaria (UAS7<=6) and patients who achieve complete response (UAS7=0) •To evaluate the safety of MTPS9579A compared with placebo •To characterize the pharmacokinetic (PK) profile of MTPS9579A •To evaluate the immune response to MTPS9579A;Primary end point(s): 1. Change from baseline in the UAS7 at Week 12;Timepoint(s) of evaluation of this end point: 1. Baseline (Week 0) and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with well-controlled urticaria (UAS7 <=6) at Week 12 2. Proportion of patients who achieve complete response (UAS7 =0) at Week 12 3. Incidence and severity of adverse events, with severity determined according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS toxicity grading scale), with slight modifications for clarity and for alignment with internal practices 4. Change from baseline in targeted vital signs, physical examination findings, clinical laboratory test results, and ECG parameters 5. Serum concentration of MTPS9579A at specified timepoints 6. Prevalence and incidence of anti-drug antibodies (ADAs) to MTPS9579A during the study;Timepoint(s) of evaluation of this end point: 1-2. At Week 12 3. Up to Week 25 4. Baseline (Week 0) to Week 20 5. At Weeks 0, 1, 4, 8, 12 and 20 6. At Weeks 0, 4, 12 and 20 | — |
Countries
Canada, Poland, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann-La Roche Ltd
Outcome results
None listed