CTRI/2023/08/057118
Recruiting
Phase 3
A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active-Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg with EU-Approved Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients with Chronic Idiopathic Urticaria (CIU) who Remained Symptomatic Despite Treatment with Approved Doses of H1 Antihistamines - NI
Dr Prayag shah0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: L501- Idiopathic urticaria
- Sponsor
- Dr Prayag shah
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.
- •2\.Male or female patients 18 to 60 years of age (both inclusive) at the time of screening.
- •3\.Diagnosis of CIU refractory to H1 antihistamines at the time of randomization, as defined by all of the following:
- •?CIU diagnosis for at least 6 months.
- •?Must have been on an approved H1 antihistamine for CIU for at least 3 consecutive days immediately prior to the Day \-14 screening visit and must document current use on the day of initial screening.
- •?Presence of itch and hives for \= 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment.
- •?In\-clinic UAS \= 4 on at least 1 of the screening visit days (Day \-14, Day \-7, or Day 1\).
- •?UAS7 (range 0\-42\) \= 16 and itch component of UAS7 (range 0\-21\) \= 8 during 7 days prior to randomization.
- •4\.Willing and able to complete a daily symptom diary for the duration of the study and must not have any missing diary entries in the 7 days prior to randomization.
- •5\.Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study and for 6 months thereafter.
Exclusion Criteria
- •1\.Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 30 days prior to initial dosing (90 days for biologics).
- •2\.Clearly defined underlying etiology for chronic urticarias other than CIU.
- •3\.Evidence of parasitic infection.
- •4\.Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or any other skin disease associated with itch.
- •5\.Previous treatment with omalizumab within a year prior to screening.
- •6\.Routine doses of the following medications within 10 days prior to screening: Systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide or investigational agents such as benralizumab or dupilumab etc.
- •7\.IVIG, or plasmapheresis within 90 days prior to screening.
- •8\.Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening.
- •9\.Any H2 antihistamine use within 7 days prior to screening.
- •10\.Any LTRA (such as montelukast or zafirlukast) within 10 to 14 days prior to screening.
Outcomes
Primary Outcomes
Not specified
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