What side effects are associated with this type of intervention?

The most common treatments for Chronic Urticaria involving monoclonal antibodies targeting IgE, such as Omalizumab, include side effects like injection site reactions, headache, and nasopharyngitis. Other potential adverse effects can include upper respiratory tract infections and, less commonly, more severe allergic reactions. These treatments are generally well-tolerated, but monitoring for these side effects is recommended.

What prior FDA approvals exist?

Omalizumab (XOLAIR) is an FDA-approved monoclonal antibody that targets IgE and is used for the treatment of Chronic Idiopathic Urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment. It works by binding to IgE, thereby preventing it from attaching to mast cells and basophils, which are involved in the allergic response. This mechanism is similar to the one being studied in the trial for ADL-018.

What other types of research exist?

Promising novel alternatives to ADL-018 for Chronic Urticaria patients include omalizumab (XOLAIR), which targets IgE, and dupilumab, which targets the IL-4 receptor alpha subunit. Both have shown efficacy in treating chronic urticaria and related conditions. Additionally, tralokinumab, abrocitinib, and upadacitinib are newly approved agents for related conditions like atopic dermatitis and may offer potential benefits for chronic urticaria.

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Monoclonal Antibodies

ADL-018 vs Omalizumab for Chronic Urticaria

Verified Trial

Phase 3

Recruiting

Research Sponsored by Kashiv BioSciences, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients 18 to 75 years of age (both inclusive) at the time of screening.

Be older than 18 years old

Must not have

Clearly defined underlying etiology for chronic urticarias other than CIU.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at weeks 2, 4, 6, 8, 12, 16, 20, and 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two medications, ADL-018 and XOLAIR, to treat patients with a chronic skin condition who still have symptoms despite taking antihistamines. The medications are given as injections periodically and work by calming the immune system to reduce skin symptoms.

Who is the study for?

Adults aged 18-75 with Chronic Idiopathic Urticaria (CIU) who haven't improved on antihistamines can join. Women must use birth control or be non-childbearing, and all participants should commit to the study schedule. Excluded are those recently in other drug trials, with known causes for their hives, certain medical conditions or treatments, cancer history, substance abuse issues, or infections like hepatitis or HIV.

What is being tested?

The trial is testing ADL-018 against XOLAIR (Omalizumab), both given as injections to see which one works better for chronic hives when regular antihistamines don't help. Participants will receive either ADL-018 or XOLAIR while continuing their antihistamine treatment.

What are the potential side effects?

Possible side effects include irritation at the injection site, headaches, nausea and rare allergic reactions such as rash or breathing difficulties. Since these drugs affect the immune system's response to allergens, there may also be an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My chronic hives have a known cause other than chronic idiopathic urticaria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at weeks 2, 4, 6, 8, 12, 16, 20, and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at weeks 2, 4, 6, 8, 12, 16, 20, and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at weeks 2, 4, 6, 8, 12, 16, 20, and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Relative potency of ADL-018 and XOLAIR

Secondary study objectives

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

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

Change from baseline in the overall Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, and 24.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

10Treatment groups

Experimental Treatment

Active Control

Group I: Xolair-300 mg Main / ADL-018 300 mg Transition PeriodExperimental Treatment2 Interventions

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.

Group II: Xolair-150 mg Main / ADL-018150 mg Transition PeriodExperimental Treatment2 Interventions

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.

Group III: ADL-018 300 mg Main Treatment periodExperimental Treatment1 Intervention

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

Group IV: ADL-018 300 mg Main / ADL-018 300 mg Transition PeriodExperimental Treatment1 Intervention

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.

Group V: ADL-018 150 mg Main Treatment periodExperimental Treatment1 Intervention

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

Group VI: ADL-018 150 mg Main / ADL-018 150 mg Transition PeriodExperimental Treatment1 Intervention

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.

Group VII: Xolair-150 mg Main Treatment PeriodActive Control1 Intervention

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

Group VIII: Xolair-300 mg Main / Xolair-300 mg Transition PeriodActive Control1 Intervention

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.

Group IX: Xolair-150 mg Main / Xolair-150 mg Transition PeriodActive Control1 Intervention

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.

Group X: Xolair-300 mg Main Treatment PeriodActive Control1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies, such as omalizumab, target immunoglobulin E (IgE) to treat Chronic Urticaria. These antibodies bind to IgE, preventing it from attaching to receptors on mast cells and basophils, which are involved in the allergic response. By inhibiting this binding, the release of histamine and other inflammatory mediators is reduced, leading to fewer and less severe urticaria symptoms. This mechanism is crucial for Chronic Urticaria patients as it directly addresses the underlying allergic processes, providing relief from persistent and often debilitating symptoms.