Study to Evaluate the Therapeutic Equivalence of SYN008 Versus Xolair® in the Treatment of Patients With Refractory Chronic Spontaneous Urticaria

NCT04944602 | Unknown Phase 3

• 1 other identifier: SYSA1903-CSP-002
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

• This study is a multicenter, randomized, double-blind, parallel-group, positive-controlled phase III study to evaluate the therapeutic equivalence of SYN008 versus omalizumab for injection (Xolair®) in the treatment of CSU patients who remain symptomatic despite antihistamine treatment.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the Weekly Itch Severity Score (ISS7) at week 12

  The severity of the itch was recorded by the patient twice daily in their Diary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)

  week 12

Secondary Outcomes (7)

• The change from baseline in Urticaria Activity Score Over 7 Days (UAS7) at week 12

  week 12

• The change from baseline in Weekly Number of Hives Score (NHS7) at week 12

  week 12

• Percentage of patients with UAS7≤6

  week 12

• Correlation analysis between baseline changes of ISS7/UAS7 and baseline IgE level

  week 12

• Time to ISS7 minimal important differences (MID) response

  week 12

Study Arms (2)

SYN008

EXPERIMENTAL

patients received a dose of SYN008 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)

Biological: SYN008

Omalizumab

ACTIVE COMPARATOR

patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)

Biological: Omalizumab for injection

Interventions

SYN008 BIOLOGICAL

injection of 300 mg

SYN008

Omalizumab for injection BIOLOGICAL

injection of 300 mg

Omalizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CSU refractory to H1AH at the time of randomization, as defined by all of the following:
• CSU diagnosis for ≥ 6 months;
• The presence of itch and hives for ≥ 6 consecutive weeks within one year prior to randomization despite use of H1AH treatment during this time period;
• UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1);
• In-clinic UAS ≥ 4 on at least one of the screening visit days;
• Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the screening visit and must have documented current use on the day of the initial screening visit.
• Voluntarily sign the informed consent form. Willing and able to complete a daily symptom diary for the duration of the study, and comply with the protocol requirements.
• Patients must not have had any missing diary entries in the 7 days prior to randomization.
• Both male and female patients must agree to practice contraception from the signing of informed consent to 6 months after the last dose of study drugs.

You may not qualify if:

• Previous treatment with omalizumab within one year prior to signing the informed consent.
• Hypersensitivity to omalizumab, study drug excipients or other biosimilars, or have a history of severe drug allergy or anaphylactic shock.
• Clearly defined underlying etiology for chronic urticarias other than CSU. This includes but is not limited to:
• dermatographism (factitious urticaria);
• cold, heat, solar, delayed pressure, aquagenic, cholinergic or contact urticarias;
• Any of the following diseases, which may have symptoms of urticaria and/or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, etc.
• Patients with a stool examination positive for ova or parasites at screening. {Stool ova and parasite evaluation will only be conducted in patients with BOTH risk factors for parasitic disease (living in an endemic area, and/or chronic gastrointestinal (GI) symptoms and chronic immunosuppression, travel within the last 6 months to an endemic area) AND an absolute eosinophil count more than twice the upper limit of normal.}
• Suffer from other chronic pruritic dermatosis that may confound the results: atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.
• CSU patients who had difficulty breathing episodes due to angioedema in the past six months.
• Active infections requiring treatment at screening, include but not limited to pulmonary infection and tuberculosis.
• Patients with platelet count ≤100\*109/L at screening.
• A history of malignancy of any organ or system within 5 years prior to screening, regardless of local recurrence or metastasis {except for basal cell carcinoma, actinic keratosis, or Bowen's disease (squamous cell carcinoma in situ) that have been treated and have not recurred in the past 12 weeks; Cervical carcinoma in situ or non-invasive malignant colonic polyps that have been resected and have not recurred within the last 5 years}
• Presence of clinically significant unstable diseases:
• High risk of severe ventricular arrhythmias, such as significant left ventricular dysfunction, NYHA class III / IV;
• Myocardial infarction occurred within 6 months before screening. History of unstable angina, acute coronary syndrome or other high-risk coronary heart disease;

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Omalizumab; Injections

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ruo-Yu Li

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruo-Yu Li

CONTACT

010-66119025; mycolab@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 29, 2021
• Study Start: July 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share