A Study to Assess the Effects and the Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous UrticariaMedDRA version: 21.1Level: LLTClassification code 10009159Term: Chronic urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2021-006413-11-PL
- Lead Sponsor
- Celldex Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 168
1.Read, understood, and provided written informed consent, and Health Insurance Portability and Accountability Act (HIPAA) authorization if applicable, after the nature of the study has been fully explained.
2.Male or female, = 18 years of age at the time of signing the informed consent
3.Diagnosis of CSU = 6 months prior to Screening Visit 1
4.CSU refractory to a stable regimen of second-generation non-sedating H1AH as defined by all of the following:
•Recurrent pruritic wheals with or without angioedema for = 6 weeks at any time prior to Screening Visit 1 despite treatment with a H1AH
Note: Hives consistent with CSU should be documented and confirmed by the investigator prior to randomization
•Patients must have been on a stable regimen of daily use of a second-generation non-sedating H1AH at approved or increased (up to 4 times the approved) dose for the treatment of CSU for = 4 weeks prior to randomization and which is expected to remain stable at the time of randomization and throughout the study
•Weekly urticaria activity score (UAS7, range: 0-42) = 16 and weekly itch severity score (ISS7, range: 0-21) = 8 during the 7-day period immediately prior to randomization
5.Hemoglobin, white blood count (WBC), absolute neutrophil count (ANC), and platelets = the lower limit of normal (LLN) and = than 1.5 X the upper limit of normal (ULN) range if the values between ULN and 1.5 X ULN are deemed to be not clinically significant by the Investigator, at Screening Visits 1 and 2*
6.Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2 x ULN, and total bilirubin = ULN, at Screening Visits 1 and 2*.
*For 5 and 6 above, if test results do not meet the above criteria, a repeat test may be performed to establish eligibility.
7.Females must meet one of the following criteria:
If of childbearing potential, agree to use highly effective contraception from the time of Screening Visit 1 and for at least 150 days after receipt of study treatment. Highly effective methods of contraception include the following:
•combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, administered as oral, intravaginal or transdermal
•progestogen-only hormonal contraception associated with inhibition of ovulation administered as oral, injectable or by implantable means
•intrauterine device (IUD)
•intrauterine hormone-releasing system (IUS)
Females of non-childbearing potential, who are surgically sterile (i.e., had undergone complete hysterectomy, salpingectomy and bilateral oophorectomy) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels, are eligible.
8.Male patients must agree that while participating in the study and for at least 150 days after receipt of the study treatment, they will use highly effective methods of contraception with female partners of childbearing potential, and they will not donate sperm. Vasectomy is considered to be a highly effective method of contraception provided that the vasectomized patient has received medical assessment confirming surgical success.
9.Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout the study. Note: For study eligibility, patients need to complete the diary for at least 6 of 7 days immediately prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults
1.Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), autoimmune syndromes with urticarial lesions (e.g., Schnitzler Syndrome) and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency).
2.Active chronic inducible urticaria (CIndU) including symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria that would confound CSU assessments based on the investigator’s clinical judgment.
3.Any other active pruritic skin diseases that would confound CSU assessments (e.g., atopic dermatitis, psoriasis, bullous pemphigoid, dermatitis herpetiformis, prurigo nodularis, chronic pruritus of unknown origin) based on the investigator's clinical judgment
4.Regular (3 or more days a week) use of topical corticosteroid, topical calcineurin inhibitors or topical antihistamines, first-generation sedating antihistamines (e.g., diphenhydramine, hydroxyzine, doxylamine) and other sedatives/hypnotics (e.g., doxepin), within 1 week of Screening Visit 1.
5.Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Screening Visit 1.
6.Non-biologic systemic (oral or injectable) agents listed below, including investigational agents, within 4 weeks or 5 half-lives, whichever is longer, prior to Screening Visit 1.
Note: Non-biologic systemic (oral or injectable) agents: corticosteroids, non-steroidal immunosuppressants (e.g., methotrexate, cyclosporin, tacrolimus, mycophenolate mofetil, azathioprine, cyclophosphamide), and other immunomodulators (e.g., dapsone, sulfasalazine, hydroxychloroquine, and colchicine, Jak inhibitors, Bruton's kinase [BTK] inhibitors), anticoagulants (e.g., warfarin), antifibrinolytic agents (e.g., tranexamic acid), mast cell stabilizers (e.g., cromolyn, ketotifen), and other investigational agents
7.Biologic therapy including approved or investigational biologic agents (e.g., omalizumab, ligelizumab, dupilumab, interleukin (IL)-1 inhibitor, tumor necrosis factor (TNF) inhibitor, B-cell depleting therapy (e.g., rituximab), or other investigational monoclonal antibodies, intravenous immunoglobulin (IVIG) therapy or plasmapheresis within 3 months or 5 half-lives, whichever is longer, prior to Screening Visit 1.
8.Receipt of a live vaccine within 2 months prior to the Baseline (Day 1) Visit (patients must agree to avoid live vaccination during study treatment and within 3 months thereafter).
Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Currently authorized COVID-19 vaccines are allowed.
9.Planned or anticipated use of any prohibited medications during screening and study treatment, and follow-up.
10.Diagnosis of idiopathic anaphylaxis or a history of anaphylaxes (such as those due to Hymenoptera venom or IgE-mediated food allergy), that in the opinion of the investigator, could increase the patient’s risk for systemic hypersensitivity reactions; or any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method