ADL-018 vs Omalizumab for Chronic Urticaria

Recruiting at 3 trial locations

Overseen By Dr Prayag N shah, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kashiv BioSciences, LLC

Must be taking: H1 antihistamines

Must not be taking: Corticosteroids, Hydroxychloroquine, Methotrexate, others

Disqualifiers: Malignancy, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment called ADL-018 (an omalizumab biosimilar) for people with chronic hives, particularly those who continue to experience symptoms despite using standard antihistamines. Researchers aim to determine if ADL-018 is as effective, safe, and tolerable as the current treatment, XOLAIR, which is used for similar symptoms. The trial includes multiple groups, with some participants receiving ADL-018 and others receiving XOLAIR, to compare outcomes. Suitable candidates have had chronic hives for at least six months and continue to experience symptoms, such as itchiness and hives, despite ongoing antihistamine use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new treatment option.

Do I have to stop taking my current medications to join the trial?

Yes, you may need to stop certain medications. You must stop using systemic or topical corticosteroids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, investigational agents, IVIG, plasmapheresis, regular doxepin, H2 antihistamines, and LTRAs within specific timeframes before screening. However, you must continue using an H1 antihistamine for at least 3 consecutive days before screening.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before joining. You must not use systemic or topical corticosteroids, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or certain investigational agents within 10 days before screening. Additionally, you must stop using H2 antihistamines 7 days before, and LTRA medications 10 to 14 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ADL-018, a drug similar to XOLAIR (Omalizumab), has been tested for safety in treating chronic spontaneous urticaria (CSU), a type of hives. Earlier studies found ADL-018 to be safe, with no major side effects reported, indicating that patients generally tolerated it well. These results align with those for XOLAIR, which is already approved for treating CSU. Overall, current research suggests both treatments are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ADL-018 for chronic urticaria because it could offer a new approach compared to the standard treatment, Xolair (omalizumab). While both ADL-018 and Xolair use omalizumab, a monoclonal antibody that targets IgE to reduce allergic responses, ADL-018 might have a different formulation or dosing schedule that can improve patient outcomes. The possibility of achieving similar or better results with potentially fewer injections or a different treatment regimen makes ADL-018 an intriguing option for those with chronic urticaria. This could lead to more personalized and flexible treatment plans for patients suffering from this condition.

What evidence suggests that this trial's treatments could be effective for chronic urticaria?

This trial will compare ADL-018, a biosimilar to Xolair (omalizumab), with Xolair itself for treating chronic hives. Studies have shown that ADL-018 produces positive results in treating chronic hives, matching Xolair in safety and effectiveness. Previous research on Xolair demonstrated its ability to significantly reduce hives and improve the quality of life for individuals with chronic spontaneous hives. Both ADL-018 and Xolair lower the activity of IgE, a protein involved in allergic reactions, which helps control symptoms. Overall, evidence supports the effectiveness of both ADL-018 and Xolair in managing chronic hives symptoms. Participants in this trial will receive either ADL-018 or Xolair, with various treatment arms assessing different dosages and transition periods. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.

I agree to use birth control during and for 6 months after the study.

I am a woman who cannot have children due to surgery or menopause.

Exclusion Criteria

I do not have a history of severe allergies, significant diseases, substance abuse, or current pregnancy.

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).

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Treatment

Participants receive ADL-018 or XOLAIR every 4 weeks for 24 weeks, including a 12-week main treatment period and a 12-week transition period

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADL-018
• XOLAIR (Omalizumab)

Trial Overview 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.

How Is the Trial Designed?

Group I: Xolair-300 mg Main / ADL-018 300 mg Transition Period Experimental Treatment 2 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 Period Experimental Treatment 2 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 period Experimental Treatment 1 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 Period Experimental Treatment 1 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 period Experimental Treatment 1 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 Period Experimental Treatment 1 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 Period Active Control 1 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 Period Active Control 1 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 Period Active Control 1 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 Period Active Control 1 Intervention

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

ADL-018 is already approved in European Union, United States for the following indications:

Approved in European Union as XOLAIR for:

• Chronic idiopathic urticaria
• Severe persistent allergic asthma
• Chronic rhinosinusitis with nasal polyps

Approved in United States as XOLAIR for:

• Chronic idiopathic urticaria
• Severe persistent allergic asthma
• Chronic rhinosinusitis with nasal polyps
• IgE-mediated food allergy

Who Is Running the Clinical Trial?

Kashiv BioSciences, LLC

Lead Sponsor

Trials

4

Recruited

1,200+

COD Research Private Ltd

Collaborator

Trials

2

Recruited

630+

Published Research Related to This Trial

In a study of 11 patients with chronic spontaneous urticaria, 9 achieved complete resolution of symptoms after treatment with omalizumab, with an average time to remission of 9.3 weeks.

Omalizumab was found to be safe, as no side effects were reported during the treatment, indicating its potential as an effective option for patients unresponsive to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab for urticaria treatment in clinical practice: a case series. Lesiak, A., Bednarski, IA., Maćkowska, A., et al.[2022]

Omalizumab (Xolair) is an effective treatment for moderate-to-severe persistent asthma in patients aged 12 and older who have a positive reaction to allergens and whose symptoms are not well controlled by inhaled corticosteroids, based on data from over 5,243 patients in 12 clinical trials.

The safety profile of omalizumab is comparable to that of placebo or standard therapy, indicating it is a well-tolerated option for managing IgE-mediated asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. Deniz, YM., Gupta, N.[2022]

Omalizumab is an effective add-on therapy for patients with chronic spontaneous urticaria, significantly reducing itching and hives severity, and improving quality of life compared to placebo in well-controlled trials lasting 12 to 24 weeks.

The treatment is generally well tolerated, with adverse events similar in frequency and severity to those experienced by placebo recipients, primarily involving mild to moderate headaches and upper respiratory infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab: a review of its use in patients with chronic spontaneous urticaria. McCormack, PL.[2021]

A study involving 6038 patients showed that nearly all individuals starting treatment with omalizumab had previously used multiple asthma medications, indicating that they were likely experiencing severe asthma symptoms despite existing treatments.

A significant number of new omalizumab users had recent asthma-related emergency room visits (up to 36% in Medicaid) or hospitalizations, highlighting the need for effective management in patients with moderate to severe persistent allergic asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases. Lafeuille, MH., Duh, MS., Zhang, J., et al.[2015]

In a study of 7 patients with various types of physical urticaria, treatment with omalizumab (Xolair®) led to complete symptom control within days for 5 patients, demonstrating its rapid efficacy.

Omalizumab was found to be a safe and effective option for patients who had previously struggled with physical urticaria for years and had not responded to standard antihistamines or other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-immunoglobulin E treatment of patients with recalcitrant physical urticaria. Metz, M., Altrichter, S., Ardelean, E., et al.[2015]

Chronic urticaria affects many patients, with about 50% not responding to standard treatment with second-generation H1-antihistamines, highlighting the need for effective alternatives.

Omalizumab (Xolair™) is the only licensed treatment for patients who do not respond to antihistamines, showing a favorable safety profile and good tolerability in clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab for the treatment of chronic urticaria. Zuberbier, T., Maurer, M.[2015]

CMAB007, a biosimilar of omalizumab, was well-tolerated in a study involving 36 healthy Chinese men, with no drug-related adverse events reported, indicating a favorable safety profile.

The treatment effectively reduced free IgE levels by 91.9-98.8% in a dose-dependent manner, demonstrating its pharmacodynamic efficacy and supporting its potential for further clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects. Zhou, B., Lin, B., Li, J., et al.[2021]

Omalizumab, a monoclonal antibody used to treat IgE-mediated diseases, has a low incidence of anaphylaxis, reported in only 0.1% of asthma patients during clinical trials and estimated at 0.2% in post-marketing studies.

A post-marketing study found no correlation between anaphylaxis or skin test reactions and the presence of IgE antibodies to omalizumab, suggesting that the risk of anaphylaxis may not be related to the drug's immunogenicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis. Baker, DL., Nakamura, GR., Lowman, HB., et al.[2018]

Citations

1. clinicaltrialsarena.com clinicaltrialsarena.com/news/kashiv-xolair-biosimilar/

Kashiv reports positive results from trial of Xolair biosimilar Kashiv has reported positive topline outcomes from the confirmatory trial of the proposed biosimilar to Novartis' Xolair, ADL-018.

2. biospace.com biospace.com/press-releases/kashiv-biosciences-announces-positive-topline-results-from-confirmatory-efficacy-study-of-adl-018-biosimilar-candidate-to-xolair-omalizumab

Kashiv BioSciences Announces Positive Topline Results ... Positive results from the confirmatory clinical efficacy and safety study of ADL-018, proposed biosimilar to XOLAIR®; The clinical study met ...

3. advanzpharma.com advanzpharma.com/news/2025/positive-top-line-results-from-confirmatory-efficacy-study-for-proposed-biosimilar-to-xolair-omalizumab

Positive Top Line Results from Confirmatory Efficacy Study ... The study met its primary endpoint, with data demonstrating equivalence of therapeutic endpoints and comparable safety between the biosimilar ...

4. investors.amneal.com investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Highlights-Positive-Topline-Results-from-Confirmatory-Clinical-Study-of-Biosimilar-Candidate-to-XOLAIRR-omalizumab-Developed-by-Kashiv-BioSciences/default.aspx

Amneal Highlights Positive Topline Results from Confirmatory ... The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12128672/

Efficacy and safety of CT‐P39, an omalizumab biosimilar ... Improvements in efficacy outcomes observed in the TPs gradually decreased during the follow‐up period, but did not return to baseline values.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf

highlights of prescribing information - accessdata.fda.gov Omalizumab-igec is biosimilar* to XOLAIR® (omalizumab) ... The safety of omalizumab for the treatment of chronic spontaneous urticaria (CSU) was assessed.

7. withpower.com withpower.com/trial/phase-3-urticaria-4-2023-7e3d0

ADL-018 vs Omalizumab for Chronic Urticaria Omalizumab was found to be safe, as no side effects were reported during the treatment, indicating its potential as an effective option for patients ...

8. investors.alvotech.com investors.alvotech.com/news-releases/news-release-details/positive-top-line-results-confirmatory-efficacy-study-proposed

Positive Top Line Results from Confirmatory Efficacy Study ... The randomized, double-blind, multicenter study assessed the efficacy, safety, and immunogenicity of AVT23 compared to Xolair® in patients with ...