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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at weeks 2, 4, 6, 8, 12, 16, 20, and 24
Awards & highlights

Study Summary

This trial tests a new drug vs XOLAIR to treat hives that don't respond to antihistamines.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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

Find a Location

Who is running the clinical trial?

Kashiv BioSciences, LLCLead Sponsor
3 Previous Clinical Trials
558 Total Patients Enrolled
COD Research Private LtdOTHER_GOV
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

ADL-018 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05774639 — Phase 3
Chronic Urticaria Research Study Groups: Xolair-150 mg Main / ADL-018150 mg Transition Period, Xolair-150 mg Main Treatment Period, ADL-018 150 mg Main / ADL-018 150 mg Transition Period, ADL-018 150 mg Main Treatment period, Xolair-300 mg Main / Xolair-300 mg Transition Period, ADL-018 300 mg Main Treatment period, ADL-018 300 mg Main / ADL-018 300 mg Transition Period, Xolair-300 mg Main / ADL-018 300 mg Transition Period, Xolair-150 mg Main / Xolair-150 mg Transition Period, Xolair-300 mg Main Treatment Period
Chronic Urticaria Clinical Trial 2023: ADL-018 Highlights & Side Effects. Trial Name: NCT05774639 — Phase 3
ADL-018 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05774639 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults of age 20 years and above eligible for this trial?

"The requirements for enrolment in this clinical trial stipulate that the minimum age of participants is 18 and the maximum age cap stands at 75."

Answered by AI

How many venues are managing this research?

"This research is currently recruiting participants at 4 distinct sites: Brooksville, Miami Lakes, and West Lafayette plus another 4 locations. To reduce the need for travel upon joining this trial, individuals should choose a medical centre closest to them."

Answered by AI

What potential risks do individuals face when taking ADL-018 150 mg during the main treatment period?

"There is notable clinical evidence in support of the safety profile for ADL-018 150 mg Main Treatment period, thus it has been rated a 3. This rating indicates that this Phase 3 trial possesses data demonstrating its efficacy and many rounds of information showing how safe it can be."

Answered by AI

Is enrollment available for this experiment at the moment?

"Clinicaltrials.gov states that this trial, originally posted on August 9th 2023 and last updated July 26th 2023, is not open for recruitment at the present time. However, there are still 32 other clinical trials actively accepting candidates right now."

Answered by AI

Is it possible to join the clinical trial I have heard about?

"This clinical trial is enrolling 600 individuals aged 18-75 diagnosed with chronic urticaria. Furthermore, participants must be capable of giving informed consent and adhering to the structured visit scheme; they should have been on a H1 antihistamine for at least 3 days prior to screening and display UAS ≥ 4 during any one of the three visits before randomization. Additionally, their daily symptom diary entries must not be missing in the week leading up to randomisation. Lastly, women who are of childbearing potential need acceptable contraception throughout the study and 6 months afterwards while postmenopausal females need an amenorrhea period lasting 1 year"

Answered by AI

What is the desired outcome of this experiment?

"The goal of this 12 week research initiative is to compare the Change from Baseline at Week 12 between ADL-018 300 mg and XOLAIR 300 mg. Secondary objectives include comparing changes in UAS7, overall Dermatology Life Quality Index (DLQI) score, and weekly number of hives (urticaria) score (HSS7)."

Answered by AI

Who else is applying?

What site did they apply to?
Stryde Research – Doc of Internal Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have tried allergy shots, allergy medications, and multiple diagnostic testing and nothing was solved.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
2023. "Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05774639.
All > Frisco
~300 spots leftby Dec 2024
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