assignment
RecruitingA Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria
- Trial ID
- 2025-522878-36-00
- Protocol
- CDX0159-17
- Sponsor
- Celldex Therapeutics Inc.
Trial statistics
science
2
test molecules
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127
research sites
public
16
countries
medical_information
1
disease
person_search
151
investigators
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10
vendors
Diseases & Conditions
Objectives
The primary objective of this study is to determine the time to disease worsening or treatment failure through Week 52 in participants with chronic spontaneous urticaria. 5: Efficacy.
The secondary objectives include:
- Determining the extent of disease control in the observation group and the barzolvolimab retreatment group through the end of study.
- Assessing safety and tolerability in the retreatment group and evaluating safety in the observation group based on the status of barzolvolimab retreatment. 4: Safety.
Participants
This clinical trial includes 932 participants diagnosed with chronic spontaneous urticaria. The study population consists of both male and female patients. The primary objectives of the study are:
- To determine the time to disease worsening.
- To determine the time to treatment failure through Week 52.
Plans and Procedures
This Phase 3b clinical trial is a long-term efficacy and safety extension study designed to evaluate barzolvolimab in participants diagnosed with chronic spontaneous urticaria. The study focuses on participants who have previously completed 52 weeks of treatment and a 16-week follow-up in either the CDX0159-12 or CDX0159-13 clinical trials. The primary objective is to determine the time to disease worsening or treatment failure through Week 52. Participants are categorized into two groups: an observation group and a retreatment group. Study procedures include the maintenance of a daily symptom diary throughout the extension period. The duration of participant involvement extends through the 52-week observation period until the end-of-study visit. Early termination may occur due to lack of efficacy, the occurrence of treatment-related adverse events, or the use of prohibited medication.
Treatment
The investigational medicinal product is barzolvolimab, administered as a solution for injection in pre-filled syringe. The dosage is 300 mg via subcutaneous injection.
The auxiliary treatment consists of epinephrine, provided as a solution for injection in pre-filled pen. The dosage is 600 µg via subcutaneous injection.
Efficacy
The primary efficacy endpoint is the time to disease worsening or treatment failure through Week 52. Treatment failure is defined by the first occurrence of an Urticaria Activity Score over 7 days (UAS7) ≥ 16, discontinuation of barzolvolimab due to lack of efficacy or a treatment-related adverse event, or the first use of prohibited medication.
Secondary efficacy parameters include the following:
- In the observation group, the change from baseline in UAS7 is assessed at Week 26 and at end-of-study (EOS).
- For participants with at least well-controlled disease (UAS7 ≤ 6) at baseline, the percentage of participants maintaining at least well-controlled disease is evaluated at Week 26 and EOS.
- For participants with complete control (UAS7 = 0) at baseline, the percentage of participants with at least well-controlled disease is evaluated at Week 26 and EOS.
- For participants with chronic spontaneous urticaria completely controlled (UAS7 = 0 and Angioedema Activity Score over 7 days [AAS7] = 0) at baseline, the percentage of participants with completely controlled disease is evaluated at Week 26 and EOS.
- The time to loss of well-controlled disease, complete control, or completely controlled disease is measured through EOS in the observation group.
- In the retreatment group, the change from LTE baseline UAS7 is measured at Week 12, Week 24, Week 52, and EOS.
- The percentage of participants in the retreatment group with UAS7 ≤ 6 is assessed at Week 12, Week 24, Week 52, and EOS.
Inclusion and Exclusion Criteria
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Inclusion Criteria
- Able to read, understand, and provide written informed consent themselves, and if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization, after the nature of the study has been fully explained, and must be willing to comply with all study requirements and procedures
- Must have completed 52 weeks of treatment and the 16-week follow-up in one of the CDX0159-12 or CDX0159-13 clinical studies
- In the opinion of the Investigator, is eligible to participate in the LTE based on a favorable benefit-risk assessment. For participants receiving barzolvolimab retreatment, participants remain eligible to continue treatment in the LTE by not meeting any of the criteria during CDX0159-12 or CDX0159-13 that would have warranted study drug discontinuation.
- Female participants receiving barzolvolimab retreatment at study entry must meet 1 of the following criteria: • If of childbearing potential, agrees to use highly effective contraception from the time of Visit 1 and for 150 days after the 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) − a vasectomized male partner (male sterilization ≥ 6 months prior to Visit 1 with a medical assessment of the surgical success) as the sole partner for the participant Total abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (eg, calendar, ovulation, symptothermal postovulation methods) and withdrawal are not acceptable methods of contraception. The decision on the contraceptive method should be reviewed every 2 months to evaluate the individual need and compatibility of the method chosen if the participant will receive barzolvolimab or receives barzolvolimab at any time during the study. • Females of non-childbearing potential, who are surgically sterile (ie, had undergone complete hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or bilateral tubal ligation) or in a menopausal state (≥ 1 year without menses), or confirmed by follicle-stimulating hormone (FSH) levels, are eligible.
- Male participants receiving barzolvolimab retreatment at study entry and with female partners of childbearing potential must agree to use barrier contraceptive methods or have undergone a vasectomy and agree not to donate sperm during the study and for at least 150 days after receipt of study treatment. Additionally, male participants with female partners of childbearing potential must agree to discuss with their partner the use of highly effective contraception methods during the same period of time. When a male participant has undergone a vasectomy, the participant’s medical history should show that the vasectomized participant has documented medical assessment confirming the surgical success of the vasectomy.
- Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom Diary during the final month of the CDX0159-12 or CDX0159-13 and throughout the LTE study.
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Exclusion Criteria
- Any other active pruritic skin diseases that would confound CSU assessments (eg, atopic dermatitis, psoriasis, bullous pemphigoid, dermatitis herpetiformis, prurigo nodularis, chronic pruritus of unknown origin) based on the Investigator’s clinical judgment.
- 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.
- Prohibited non-biologic systemic agents, including investigational agents, within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- Immunomodulating biologic therapy within 3 months prior to enrollment
- Participants in Group 2 (Barzolvolimab Retreatment Group): Women who are pregnant or nursing. All female participants with reproductive potential must have a negative pregnancy test prior to starting barzolvolimab study treatment.
- Severe or uncontrolled chronic diseases (eg, chronic hepatic or renal disease, diabetes mellitus) that might interfere with the evaluation of the clinical effect or safety of study treatment or may confound assessment of safety during the trial
- Participants with moderate-to-severe pulmonary or cardiovascular diseases.
- Known active hepatitis B, hepatitis C, or HIV infection.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics, or antiprotozoals during the enrollment review. The enrollment review may be extended by 2 weeks to allow for recovery of acute infections independent of requirement for anti-infective treatment
- History of malignancy within 5 years before enrollment review, except fully treated carcinoma in-situ of the cervix, fully treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
- Procedures requiring general or epidural anesthesia within 8 weeks prior to study treatment, minor procedures (eg, dental) within 14 days prior to study treatment, or anticipation of procedures requiring general anesthesia during study participation.
- Prior receipt of any investigational product or other anti-KIT therapy (other than barzolvolimab).
- Inadequate compliance with the Diary during CDX0159-12 or CDX0159-13 sufficient to lead to unacceptable safety risk to study participation, according to the Investigator.
- Participants who live in detention on court order or on regulatory action will not be enrolled.
- Sponsor or contract research organization (CRO) staff directly involved in the conduct of the study, site staff supervised by the Investigator, and their respective family members.
- Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Recruiting | 13 May 2026 | 6 |
 Bulgaria | Recruiting | 13 May 2026 | 102 |
 Croatia | Not Yet Recruiting | 13 May 2026 | 3 |
 Czechia | Not Yet Recruiting | 13 May 2026 | 4 |
 Denmark | Recruiting | 13 May 2026 | 5 |
 France | Recruiting | 13 May 2026 | 14 |
 Germany | Recruiting | 13 May 2026 | 48 |
 Greece | Recruiting | 13 May 2026 | 8 |
 Hungary | Not Yet Recruiting | 13 May 2026 | 6 |
 Italy | Recruiting | 13 May 2026 | 16 |
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Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
BARZOLVOLIMAB | Test | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | SUBCUTANEOUS INJECTION | 300 | 48 | PRD11655867 |
FASTJEKT
300 Mikrogramm, Injektionslösung im Fertigpen | Other | INJEKTIONSLÖSUNG IM FERTIGPEN | SUBCUTANEOUS INJECTION | 600 | 1 | PRD527695 |
Conditions Studied in This Trial
Interventions Studied in This Trial
vaccines
Epinephrine
25 trials
vaccines
Barzolvolimab
7 trials