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

NCT05774639 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: KBS/OMA/01
• Study Type: interventional
• Target: 600
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Chronic Idiopathic Urticaria

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the ISS7 at Week 12 between ADL-018 300 mg and XOLAIR 300 mg

  ISS 7 is a weekly itch severity score calculated as sum of the daily itch severity score for 7 days, on a scale of 0 to 3 (0=none to 3=intense/severe)

  Change from Baseline at week 12

• Relative potency of ADL-018 and XOLAIR

  Relative potency ADL-018 to the Xolair defined as the dose of ADL-018 that produces the same biological response as one unit of the dose of the Xolair. The relative potency and its CI will be measured by change in ISS7 at Week 12 using a 4 point assay based on the 300 mg and 150 mg dose levels of each product.

  Change from Baseline at week 12

Secondary Outcomes (7)

• Change from baseline in the ISS7 at Week 2, 4, 6, 8, 16, 20, and 24

  Change from Baseline at Week 2, 4, 6, 8, 16, 20, and 24

• Change from baseline in UAS7 at Weeks 2, 4, 6, 8, 12, 16, 20, and 24

  Change from Baseline at Weeks 2, 4, 6, 8, 12, 16, 20, and 24

• Change from baseline in weekly number of hives (urticaria) score (HSS7) at Weeks 2, 4, 6, 8, 12, 16, 20, and 24

  Change from Baseline at Weeks 2, 4, 6, 8, 12, 16, 20, and 24.

• Percentage of patients with angioedema-free days from Week 4 to Week 12

  change from Week 4 to Week 12

• Percentage of complete responders (UAS7=0) at Week 12

  change from baseline at week 12

Study Arms (10)

ADL-018 300 mg Main Treatment period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Drug: Omalizumab Injection

Xolair-300 mg Main Treatment Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8

Drug: Xolair Prefilled Syringe

ADL-018 150 mg Main Treatment period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Drug: Omalizumab Injection

Xolair-150 mg Main Treatment Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8

Drug: Xolair Prefilled Syringe

ADL-018 300 mg Main / ADL-018 300 mg Transition Period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to ADL-018 300 mg in the Main Treatment period.

Drug: Omalizumab Injection

Xolair-300 mg Main / ADL-018 300 mg Transition Period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.

Drug: Omalizumab Injection; Drug: Xolair Prefilled Syringe

Xolair-300 mg Main / Xolair-300 mg Transition Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.

Drug: Xolair Prefilled Syringe

ADL-018 150 mg Main / ADL-018 150 mg Transition Period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to ADL-018150 mg in the main treatment period.

Drug: Omalizumab Injection

Xolair-150 mg Main / ADL-018150 mg Transition Period

EXPERIMENTAL

ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR-150 mg in the main treatment period.

Drug: Omalizumab Injection; Drug: Xolair Prefilled Syringe

Xolair-150 mg Main / Xolair-150 mg Transition Period

ACTIVE COMPARATOR

XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR -150 mg in the main treatment period.

Drug: Xolair Prefilled Syringe

Interventions

Omalizumab Injection DRUG

ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)

Also known as: ADL-018

ADL-018 150 mg Main / ADL-018 150 mg Transition Period; ADL-018 150 mg Main Treatment period; ADL-018 300 mg Main / ADL-018 300 mg Transition Period; ADL-018 300 mg Main Treatment period; Xolair-150 mg Main / ADL-018150 mg Transition Period; Xolair-300 mg Main / ADL-018 300 mg Transition Period

Xolair Prefilled Syringe DRUG

XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution

Xolair-150 mg Main / ADL-018150 mg Transition Period; Xolair-150 mg Main / Xolair-150 mg Transition Period; Xolair-150 mg Main Treatment Period; Xolair-300 mg Main / ADL-018 300 mg Transition Period; Xolair-300 mg Main / Xolair-300 mg Transition Period; Xolair-300 mg Main Treatment Period

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead
• COD Research Private Ltd: collaborator

Study Sites (6)

True Blue Clinical Research

Brandon, Florida, 33511, United States

Location

Access Research Institute

Brooksville, Florida, 34613, United States

Location

San Marcus research Clinic, Inc

Miami Lakes, Florida, 33014, United States

Location

Options Research Group

West Lafayette, Indiana, 47906, United States

Location

Site 001

Mumbai, Maharashtra, India

Location

Al Essra Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be parallel study to compare efficacy, safety and immunogenicity of ADL-018 150 and 300 mg doses in comparison with US-licensed XOLAIR 150 and 300 mg

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 17, 2023
• Study Start: August 15, 2023
• Primary Completion: October 3, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IN (1); JO (1)