ADL-018 vs Omalizumab for Chronic Urticaria
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Kashiv BioSciences, LLC
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
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.
What data supports the idea that ADL-018 vs Omalizumab for Chronic Urticaria is an effective drug?
The available research shows that Omalizumab, a drug similar to ADL-018, is effective in treating chronic urticaria. In clinical trials, Omalizumab significantly reduced itching and the number and size of hives in patients who did not respond to standard antihistamines. It also improved patients' quality of life and reduced the number of days with swelling. Most side effects were mild or moderate, making it a well-tolerated option. This suggests that ADL-018, being similar, could also be effective for this condition.
12345What safety data is available for ADL-018 and Omalizumab in treating chronic urticaria?
Omalizumab (Xolair) has been extensively studied for safety. In clinical trials for chronic spontaneous urticaria, it was generally well tolerated with adverse events similar to placebo, mainly mild or moderate, such as headache and upper respiratory infections. Anaphylaxis was rare, occurring in 0.1% of asthma patients in pre-marketing trials and at least 0.2% in post-marketing reports. A biosimilar, CMAB007, showed no drug-related adverse events in healthy subjects. Overall, omalizumab is considered safe and well-tolerated for treating chronic urticaria.
12367Is the drug ADL-018 (Omalizumab) a promising treatment for chronic urticaria?
Yes, ADL-018 (Omalizumab) is a promising treatment for chronic urticaria. It has been shown to significantly reduce itching, hives, and improve quality of life for patients who do not respond to standard antihistamine treatments. It is well-tolerated and is the only licensed treatment for chronic urticaria that doesn't respond to antihistamines.
12348Eligibility Criteria
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
I am between 18 and 75 years old.
I agree to use birth control during and for 6 months after the study.
Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.
+2 more
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).
You have signs of a parasitic infection.
+2 more
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stryde Research – Epiphany DermatologySouthlake, TX
Stryde Research – Doc of Internal MedicinePlano, TX
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Who Is Running the Clinical Trial?
Kashiv BioSciences, LLCLead Sponsor
COD Research Private LtdCollaborator
References
Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis. [2018]Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab is used to treat IgE-mediated diseases such as chronic idiopathic urticaria (CIU) and moderate to severe allergic asthma. In pre-marketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3,507 (0.1%) patients. In post-marketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. To better understand the risk of anaphylaxis in patients with allergic asthma receiving omalizumab, a post-marketing pharmacosurveillance study was initiated in 2009. As part of this study, an assay was developed to detect antibodies of IgE isotype to omalizumab. Serum samples from patients in the study were evaluated using this assay. Our results indicated that there was no observable correlation between either anaphylaxis or skin test reactivity and the presence of antibodies of IgE isotype to omalizumab. Here, we discuss the development of this assay as well as the results of the immunogenicity assessment.
Omalizumab: a review of its use in patients with chronic spontaneous urticaria. [2021]Omalizumab (Xolair(®)) is a humanized, recombinant, IgG, anti-IgE monoclonal antibody that binds to the Fc region of free IgE and prevents it from binding to its high-affinity receptor (FcεR1) on mast cells and basophils. This reduction in free IgE leads to a reduction in mast cell/basophil degranulation and the release of histamine, and to the down-regulation of FcεR1 receptors on these cells. Omalizumab does not bind to cell-bound IgE or to IgG. In well-controlled clinical trials in patients with chronic spontaneous urticaria and persistent symptoms despite background treatment with antihistamines, add-on therapy with subcutaneous omalizumab 300 mg every 4 weeks for 12 or 24 weeks significantly reduced the severity of itching, and the number and size of hives, and increased patients' health-related quality of life and the proportion of days free from angioedema compared with placebo. Subcutaneous omalizumab was generally well tolerated; the incidence and severity of adverse events in omalizumab recipients were similar to those in placebo recipients, and most adverse events were of mild or moderate severity. The only adverse events occurring more frequently with omalizumab than with placebo during treatment in a safety study were headache and upper respiratory tract infection. Thus, omalizumab is an effective and well-tolerated add-on therapy in patients with chronic spontaneous urticaria who are symptomatic despite background therapy with H1 antihistamines.
Omalizumab for urticaria treatment in clinical practice: a case series. [2022]Omalizumab (Xolair) originally intended to reduce symptoms of moderate to severe asthma uncontrollable with steroids is the first monoclonal antibody approved for treatment of chronic spontaneous urticaria in 2014.
Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases. [2015]Omalizumab (Xolair®) is a monoclonal antibody indicated for moderate to severe persistent allergic asthma patients with symptoms that are inadequately controlled with inhaled corticosteroids (ICS).
Anti-immunoglobulin E treatment of patients with recalcitrant physical urticaria. [2015]In physical urticaria, exogenous physical factors such as thermal triggers, solar radiation and mechanic triggers including friction or pressure are responsible for the elicitation of symptoms in the skin of patients. Avoidance of the respective stimulus is usually difficult or impossible, and many patients are not sufficiently treated with standard antihistamines. We report that treatment with omalizumab (Xolair®) of 7 patients with physical urticarias [solar urticaria (n = 2), urticaria factitia/symptomatic dermographism (n = 2), cold urticaria, delayed pressure urticaria and localized heat urticaria] resulted in complete symptom control within days after the first injection in 5 patients. In 1 patient, symptoms improved after increasing the dose of omalizumab, and 1 patient with localized heat urticaria did not respond significantly to treatment. Before anti-immunoglobulin E treatment, all patients had suffered from their physical urticaria for years and had had numerous unsuccessful therapies. The overall excellent responses to omalizumab treatment reported here indicate that anti-immunoglobulin E is a safe and effective treatment for recalcitrant physical urticarias.
Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects. [2021]The goal of the studies presented here was to determine the tolerability, pharmacokinetic and pharmacodynamic profiles of CMAB007, a biosimilar of omalizumab (Xolair; a humanized anti-immunoglobulin E monoclonal antibody), in healthy, male Chinese subjects. Thirty-six healthy Chinese men participated in two open-label, dose-escalation studies: 27 in a single-dose study (150, 300 or 600 mg) and 9 in a multiple-dose study (150 or 300 mg every 4 weeks for 20 weeks). The safety profiles of both studies were generally unremarkable. No drug-related adverse event was observed. CMAB007 exhibited a linear PK profile over the dose range of 150-600 mg. In the single-dose study, maximum concentration (Cmax) was reached within 6-8 d, and Cmax and area under concentration-time curve (AUC) increased linearly with the dose. In the multiple-dose study, steady-state appeared to have been achieved after the third dose. Css-max and AUCτ also showed dose-linearity. A dose-dependent suppression of free IgE was observed during treatment, as a median percentage change from baseline, 91.9-98.8%, in the three single-dose groups. No anti-CMAB007 antibodies were detected after dosing in any subject. Subcutaneous administration of CMAB007 was well-tolerated and seemed to be effective in reducing free IgE in healthy Chinese volunteers, which provides important information for further clinical studies.
Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. [2022]Omalizumab (Xolair) is a humanized monoclonal antibody designed to bind specifically to immunoglobulin (Ig)E. It is indicated in the United States for the treatment of adolescent and adult patients (>or=12 yr) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. Omalizumab was evaluated in an extensive clinical development program that included 12 controlled phase IIB/III clinical trials with more than 5,243 patients who were appropriate for inclusion in the safety analysis (all ages in all controlled studies). In these studies, omalizumab had an adverse event profile comparable to that of the control group (i.e., placebo or standard therapy). Data presented in this article supports omalizumab as a safe and well-tolerated agent for the treatment of IgE-mediated asthma.
Omalizumab for the treatment of chronic urticaria. [2015]Urticaria is a common and often debilitating dermatological condition defined by the sudden appearance of wheals, angioedema or both. It is further classified into specific subtypes based on duration and specific triggers. Awareness and understanding of urticaria are important to ensure a correct initial diagnosis and initiate appropriate guideline-based treatment outlining a stepwise approach. However, in chronic urticaria, approximately 50% of patients are refractory to the first step, the use of licensed doses of second-generation H1-antihistamines. If the second step, an increase in the dose of the second-generation H1-antihistamines, is also not successful, in the third step omalizumab (Xolair™, Novartis Pharma AG(©)/Genentech, Inc.(©)), an anti-IgE therapy, is recommended as an add-on. Of all alternative treatments mentioned in the guidelines, omalizumab is currently the only licensed treatment for H1-antihistamine-refractory chronic spontaneous urticaria, has a favorable risk/benefit ratio and was well tolerated in clinical studies.