Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Completed · Phase 3

Conditions studied: Chronic Idiopathic Urticaria

In brief

The purpose of the study is to compare the efficacy, safety, tolerability, and immunogenicity of ADL-018 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment

Key facts

Study ID

NCT05774639

Run by

Kashiv BioSciences, LLC

People needed

600

Starts

2023-08-15

Expected to finish

2024-12-31

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.
• Male or female patients 18 to 75 years of age (both inclusive) at the time of screening.
• 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.
• 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.
• Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study and for 6 months thereafter.
• Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone serum levels consistent with postmenopausal status.

You may not qualify if…

• 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).
• Clearly defined underlying etiology for chronic urticarias other than CIU.
• Evidence of parasitic infection.
• Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or any other skin disease associated with itch.
• Previous treatment with omalizumab within a year prior to screening.
• 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.
• IVIG ( Intravenous immune globulin) or plasmapheresis within 90 days prior to screening.
• Regular (daily/every other day) doxepin (oral) use within 14 days prior to screening.
• Any H2 antihistamine use within 7 days prior to screening.
• Any LTRA (Leukotriene receptor antagonists such as montelukast or zafirlukast) within 10 to 14 days prior to screening.
• Patients with current malignancy, history of malignancy, or currently under work-up for suspected malignancy except non-melanoma skin cancer that has been treated or excised and is considered resolved.
• Hypersensitivity to omalizumab or any component of the formulation.
• History of anaphylactic shock.
• Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients.
• Medical examination or laboratory findings that suggest the possibility of decompensation of co-existing conditions for the duration of the study.
• Evidence of current drug or alcohol abuse.
• Positive test for hepatitis B, hepatitis C, or HIV.
• Females with positive pregnancy tests at screening or any other visit.
• Females who are breastfeeding or lactating.
• History of any clinically significant disease or condition that, in the opinion of the Principal Investigator (PI)/designee, would render them unsuitable for inclusion in the study.

Where it is running

• True Blue Clinical Research — Brandon, Florida, United States
• Access Research Institute — Brooksville, Florida, United States
• San Marcus research Clinic, Inc — Miami Lakes, Florida, United States
• Options Research Group — West Lafayette, Indiana, United States
• Site 001 — Mumbai, Maharashtra, India
• Al Essra Hospital — Amman, Jordan

Full record on ClinicalTrials.gov

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