Chronic Idiopathic UrticariaPhase 3NCT05774639
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
A Phase 3 study testing Omalizumab Injection and Xolair Prefilled Syringe in people with Chronic Idiopathic Urticaria, run by Kashiv BioSciences, LLC at 6 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- Omalizumab Injection and Xolair Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 15 Aug 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Evidence of current drug or alcohol abuse.
- Positive test for hepatitis B, hepatitis C, or HIV.
- Females with positive pregnancy tests at screening or any other visit.
- Females who are breastfeeding or lactating.
- History of any clinically significant disease or condition that, in the opinion of the Principal Investigator (PI)/designee, would render them unsuitable for inclusion in the study.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
True Blue Clinical Research
Brandon, Florida, 33511
Access Research Institute
Brooksville, Florida, 34613
San Marcus research Clinic, Inc
Miami Lakes, Florida, 33014
Options Research Group
West Lafayette, Indiana, 47906
About this study
Official title: A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines
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
Read the detailed description
This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of ADL-018 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks.
At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of ADL-018 300 mg, XOLAIR 300 mg, ADL-018 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of ADL-018 (transition period) at the same dose level as prior to randomization. All patients in the ADL-018 groups will continue to receive ADL-018 at the same dose levels.
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- Omalizumab Injection, Xolair Prefilled Syringe
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab InjectionDrug
Also called ADL-018
ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)
Xolair Prefilled SyringeDrug
XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Xolair Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
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).
Measured: 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 in the Urticaria Activity Score (UAS) - sum of the daily number of wheals score and itch severity score over 7 days, range from 0 (minimum) to 6 (maximum)
Measured: 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 in the weekly number of wheals score at Week 12
Measured: 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
Percentage of angioedema-free days from Week 4 to Week 12
Measured: change from Week 4 to Week 12
Percentage of complete responders (UAS7=0) at Week 12
Percentage of complete responders with weekly Urticaria Activity Score =0 at Week 12
Measured: change from baseline at week 12
Percentage of patients achieving UAS7 ≤ 6 at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Percentage of patients with a weekly Urticaria Activity Score ≤6
Measured: Change from Baseline at Weeks 2, 4, 6, 8, 12, 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.
Change from baseline in the overall dermatology life quality index (DLQI) score at Week 12; comparisons of ADL-018 and XOLAIR treatment arms. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
Measured: Change from Baseline at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start15 Aug 2023
- Primary completion3 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COD Research Private Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774639
- Sponsor's protocol ID
- KBS/OMA/01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines
- ClinicalTrials.gov ID
- NCT05774639
- Acronym / sponsor ID
- KBS/OMA/01
- Conditions
- Chronic Idiopathic Urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- COD Research Private Ltd
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of ADL-018 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. This study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. The total duration of the study is up to 42 weeks.
At baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of ADL-018 300 mg, XOLAIR 300 mg, ADL-018 150 mg or XOLAIR 150 mg (main treatment period). At Week 12, prior to receiving their fourth dose of study medication, patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of XOLAIR (at the same dose level as prior to randomization, or switch to 3 doses of ADL-018 (transition period) at the same dose level as prior to randomization. All patients in the ADL-018 groups will continue to receive ADL-018 at the same dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| ADL-018 300 mg Main Treatment period | Experimental | Drug: Omalizumab InjectionADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
| Xolair-300 mg Main Treatment Period | Active comparator | Drug: Xolair Prefilled SyringeXOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8 |
| ADL-018 150 mg Main Treatment period | Experimental | Drug: Omalizumab InjectionADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
| Xolair-150 mg Main Treatment Period | Active comparator | Drug: Xolair Prefilled SyringeXOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8 |
| ADL-018 300 mg Main / ADL-018 300 mg Transition Period | Experimental | Drug: Omalizumab InjectionADL-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. |
| Xolair-300 mg Main / ADL-018 300 mg Transition Period | Experimental | Drug: Omalizumab Injection, Drug: Xolair Prefilled SyringeADL-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. |
| Xolair-300 mg Main / Xolair-300 mg Transition Period | Active comparator | Drug: Xolair Prefilled SyringeXOLAIR (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. |
| ADL-018 150 mg Main / ADL-018 150 mg Transition Period | Experimental | Drug: Omalizumab InjectionADL-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. |
| Xolair-150 mg Main / ADL-018150 mg Transition Period | Experimental | Drug: Omalizumab Injection, Drug: Xolair Prefilled SyringeADL-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. |
| Xolair-150 mg Main / Xolair-150 mg Transition Period | Active comparator | Drug: Xolair Prefilled SyringeXOLAIR (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omalizumab InjectionAlso: ADL-018ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS) | Drug | 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 SyringeXOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution | Drug | 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 |
Primary outcome
Change from baseline in the ISS7 at Week 12 between ADL-018 300 mg and XOLAIR 300 mg
Time frame: Change from Baseline at week 12
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)
Relative potency of ADL-018 and XOLAIR
Time frame: Change from Baseline at week 12
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.
7 secondary outcomes
Change from baseline in the ISS7 at Week 2, 4, 6, 8, 16, 20, and 24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change from Week 4 to Week 12
Percentage of complete responders (UAS7=0) at Week 12
Time frame: change from baseline at week 12
Percentage of patients achieving UAS7 ≤ 6 at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Time frame: Change from Baseline at Weeks 2, 4, 6, 8, 12, 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.
Time frame: Change from Baseline at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omalizumab Injection and Xolair Prefilled Syringe in people with Chronic Idiopathic Urticaria, run by Kashiv BioSciences, LLC at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, India, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the ISS7 at Week 12 between ADL-018 300 mg and XOLAIR 300 mg (time frame: Change from Baseline at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.