A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Prurigo Nodularis
- Conditions
- Prurigo nodularisMedDRA version: 20.0Level: LLTClassification code: 10037084Term: Prurigo nodularis Class: 10040785Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-510279-80-00
- Lead Sponsor
- Celldex Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
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. Patients must be able to provide informed consent themselves., Estimated glomerular filtration rate based on creatinine (eGFRcr) as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation is = 45 mL/min/1.73 m2, at screening*. Note: participants with renal disease may be included if this criterion is met. (*for 8, 9 and 10 above if test results do not meet the above criteria, a repeat test may be performed to determine eligibility.), Females must meet one of the following criteria: If of childbearing potential, agrees to use highly effective contraception from the time of the Screening Visit 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) • tubal ligation Females of non-childbearing potential, who are surgically sterile (i.e., had undergone complete hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels, are eligible., Male participants must agree to use barrier contraceptive methods with female partners of childbearing potential throughout the study and for at least 150 days after receiving the study treatment. Additionally, these female partners must use highly effective contraception methods during the same period. Male participants who have undergone a vasectomy, confirmed as surgically successful, are exempt from this requirement. Male participants must also agree not to donate sperm during the study and for at least 150 days after receiving the study treatment. Male participants must agree to use highly effective methods of contraception with female partners of childbearing potential during the study and must also agree to not donate sperm during the study and for at least 150 days after receipt of the study treatment., Willing and able to comply with all study requirements and procedures. Participants must comply with daily study diary completion for at least 5 of the 7 days for the 7-day period immediately preceding randomization., Male or female, = 18 years of age., Has received a diagnosis of PN by a dermatologist at least 3 months prior to the Screening Visit., A total of at least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening and Day 1 (i.e., Investigator Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score = 3, Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of = 7 during the 7-day period immediately prior to the Baseline (Day 1) Visit. Note: participant must have daily diary data for at least 5 of these 7 days to determine eligibility., Documented history before the Screening Visit that participant had inadequate response to prescription topical medications or that topical medications are m
PN due to neuropathy (e.g., small fiber neuropathy, post-herpetic itch, notalgia paresthetica, brachioradial pruritus) or psychiatric disorders (e.g., delusional parasitosis, factitious dermatitis, obsessive-compulsive disorders, schizophrenia)., Biologic therapy including approved or investigational agents (e.g., dupilumab, investigational monoclonal antibodies against IL-31 or IL-31 receptor or other monoclonal antibody) within 3 months or 5 half-lives, whichever is longer, prior to the Baseline (Day 1) Visit., Planned or anticipated use of any prohibited medications during screening and throughout the study., Receipt of a live vaccine within 2 months prior to the Baseline (Day 1) Visit (participants must agree to avoid live vaccination during study treatment and within 4 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., History of anaphylaxis., Any known contraindications or hypersensitivity to any component of study treatments, drugs of similar chemical classes (i.e., to murine, chimeric or human antibodies)., Women who are pregnant or nursing. All female participants with reproductive potential must have a negative pregnancy test prior to starting study treatment., Severe or uncontrolled chronic diseases (e.g., chronic hepatic or renal disease, diabetes mellitus) that might interfere with the evaluation of the clinical effect or safety of study treatment., Participants with moderate-to-severe pulmonary or cardiovascular diseases; see Appendix 7 for guidelines. Note: participants with symptomatic cardiovascular or pulmonary disease that requires medication should be carefully assessed and discussed with the medical monitor to assure their cardiovascular and/or pulmonary status does not increase their risk of study participation., Participants with contraindications for use of epinephrine (e.g., history of closed angle glaucoma, significant arrhythmias, myocardial infarction, or cardiomyopathy) or are taking medications that might interfere with pharmacodynamic actions of epinephrine (e.g., beta blockers)., Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or coronavirus disease of 2019 (COVID-19) infection., PN due to medications., Malignancy or a history of malignancy (Exception: fully treated skin basal cell, non-metastatic squamous cell carcinomas, or cervical intraepithelial neoplasia, or cervical carcinoma in situ with no evidence of recurrence) within five (5) years prior to Screening Visit., Other screening laboratory or electrocardiogram (ECG) findings that are considered clinically significant., Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening Visit., Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into the study., Procedures requiring general or epidural anaesthesia within 8 we
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