A Phase 3 study to compare the efficacy and safety of CT-P39 to Xolair in Patients With Chronic Spontaneous Urticaria who have symptoms despite H1-antihistamine Treatment

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-000952-36-PL
• Lead Sponsor: CELLTRION, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Each patient must meet all of the following criteria to be randomized in this study:
1. Male or female between 12 and 75 years of age (both inclusive; age limits would depend on country specific regulation).
2. Have been diagnosed with CSU for at least 6 months prior to the first study drug administration.
3. Must be diagnosed as CSU refractory to H1-antihistamine defined as below:
a) Presence of hives associated with itching for = 6 consecutive weeks at any time prior to the first study drug administration despite current use of H1-antihistamine treatment for this time period
b) Weekly itch severity score (range 0 to 21 points) = 8 points and weekly urticaria activity score (UAS7; range 0 to 42 points) = 16 points in the 7 consecutive days (Day -7 to Day -1) prior to the first study drug administration
c) Documented use of an approved dosage of nonsedating H1-antihistamine for CSU for at least 3 consecutive days immediately prior to start of patient electronic diary (eDiary) record or baseline ISS7 (Day - 7 to Day - 1)
4. Has patient eDiary entries without missing data in the 7 consecutive days (Day -7 to Day -1) prior to the first study drug administration.
5. Be willing and able to complete a patient eDiary twice daily (morning and evening) throughout the study.
6. Patient and/or their legally authorized representative are informed and will be given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form before any specific procedures.
7. Female patient must agree to use highly effective methods of contraception consistent with local regulations throughout the study period (excluding women who are not of childbearing potential). Examples include the following:
a) Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives associated with inhibition of ovulation
b) Intrauterine device or intrauterine hormone-releasing system
c) True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception.
Menopausal female patients must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential. Male patient who is sexually active with a woman of childbearing potential must agree to use highly effective method described as above or two acceptable methods of contraception (e.g., male or female condom AND additional hormonal or barrier contraceptive method other than condom by female partner) consistent with local regulations throughout the study period. Contraception is not required if either patient or his/her partner who has been surgically sterilized more than 24 weeks prior to the date of informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

A patient meeting any of the following criteria will be excluded from the study:
1. Has a chronic urticaria with clearly defined underlying etiology (e.g., physical urticaria such as acute, solar, cholinergic, heat, cold, aquagenic, pressure or contact) other than CSU or any disease with symptoms of urticaria or angioedema (e.g., urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia or generalized cancer).
2. Has a body weight of < 30 kg.
3. Has a medical history of and/or current disease including any of the following:
a) History of clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab, Chinese hamster ovary cell products, other recombinant human or humanized antibodies, H1-antihistamines, or dry natural rubber (a derivative of latex)
b) History of and/or concomitant myocardial infarction
c)History of anaphylactic shock
d) History of and/or concomitant immune complex disease (including allergic reaction type III), hyperimmunoglobulin E syndrome, autoimmune disease, or bronchopulmonary aspergillosis
e) Any active skin disease associated with itch including atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or senile pruritus
f) A known infection with human immunodeficiency virus, hepatitis B, hepatitis C, or any active infection requiring treatment, except adequately treated and completely recovered past infections
g) Any active malignancy or history of malignancy except adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ
4. Has history of and/or a current use of medications including any of the following:
a) Treatment with omalizumab or other monoclonal antibodies, protein, fusion protein, or other biologic agent targeting immunoglobulin E (IgE)
b) Treatment with an investigational drug within 4 weeks or 5 half-lives (whichever is longer) prior to the first study drug administration
c) Routine administration (i.e., daily or every other day for = 5 consecutive days) of systemic glucocorticoids, hydroxychloroquine, methotrexate, cyclosporine, azathioprine, cyclophosphamide, tacrolimus, or mycophenolate mofetil within 5 weeks prior to the first study drug administration
d) Intravenous immunoglobulin G or plasmapheresis within 5 weeks prior to the first study drug administration
e) Regular (i.e., daily or every other day for = 5 consecutive days) use of oral doxepin within 3 weeks prior to the first study drug administration
f) Use of any H2-antihistamine or leukotriene receptor antagonist within 2 weeks prior to the first study drug administration (However, continuing H2-antihistamine or leukotriene receptor antagonist treatment for disease other than CSU is allowed)
g) Use of beta-blocker therapy within 2 weeks prior to the first study drug administration
h) Use of H1-antihistamines at greater than approved doses from 3 days prior to the start of patient eDiary record or baseline ISS7 (Day
- 7 to Day - 1)
5. Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites (stool ova and parasite examination should be performed in patients who meet both the following criteria):
a) Correspond to any of risk factors for parasitic disease
• Travel within 6 months prior to the first study drug administration or living in an endemic area of parasitic infections
• Chronic gastrointestinal symptoms
• Chronic immunosupp

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified