Chronic Spontaneous Urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: LY3454738
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: LY3454738
Other descriptive name: LY3454738
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Eli Lilly & Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: --Are male or female participants from 18 to 65 years of age, inclusive, at the time of signing the informed consent document. --Have a diagnosis of CSU for at least 6 months before the screening visit. --Are taking an approved 24-hour oral dose of a second-generation H1-antihistamine for CSU for at least 10 consecutive days before the baseline visit, and agree to continue taking this medication at the same dose every day throughout the study. --Have an urticaria activity score during a 7-day period (UAS7 score) of 16 or more during the 7 consecutive days prior to the baseline visit. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: --Have a clearly defined underlying cause for chronic urticaria other than CSU. Such causes can include, but are not limited to, the following: symptomatic dermatographism (urticaria factitia); cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contacturticaria. --Have diseases, other than chronic urticaria, with urticarial or angioedema symptoms. These diseases include, but are not limited to, urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary, or acquired angioedema (for example, due to C1 inhibitor deficiency), lymphoma, leukemia, or generalized malignancy. --Have any other skin disease associated with chronic itching that, in the investigator's opinion, might influence the study evaluations and results (including, but not limited to, prurigo nodularis, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus).-- Have a current or recent acute, active infection. --Have had, within 6 months of screening, any of the following types of infection: Serious infections (requiring hospitalisation, and/or IV or equivalent intravenous antibiotic treatment), Opportunistic infections Chronic infections (duration of symptoms, signs, and/or treatment of 6 weeks or longer), Recurring infection (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). --Have human immunodeficiency virus (HIV) infection. --Have a current or past infection with hepatitis B virus (HBV) (that is, positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody) --Have a current infection with hepatitis C virus (HCV) (that is, positive for HCV ribonucleic acid [RNA])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that treatment with LY3454738 is superior to placebo as measured by patient-assessed itch severity and hive count for the treatment of adult participants with CSU;Secondary Objective: - To compare the efficacy of LY3454738 to placebo as measured by improvement in signs and symptoms of CSU - To characterize the pharmacokinetics (PK) of LY3454738;Primary end point(s): The primary efficacy endpoint is the change in UAS7 score from baseline to Week 12 in Period 2, defined as the Week 12 UAS7 score minus the baseline UAS7 score.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): --Change from baseline in ISS7 at Week 12 is the Week 12 ISS7 score minus the baseline ISS7 score. --Change from baseline in HSS7 at Week 12 is the Week 12 HSS7 score minus the baseline HSS7 score. --The proportions of participants who achieve a UAS7 score =6 at Week 12 will be presented for each treatment group. Participants will be classified as nonresponders at Week 12 (that is, did not achieve UAS7 =6 at Week 12) if they have a missing UAS7 score at Week 12.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Germany, Poland, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly & Company
Outcome results
None listed