Drugs / barzolvolimab
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 met primary | ||||||
| Phase 1 | NCT04944862 | Nov 2021 → Jul 2023 | prurigo nodularis | Celldex Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05031624 | Aug 2021 → Jan 2022 | — | Celldex Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04548869 | Nov 2020 → Dec 2022 | cholinergic urticaria, cold urticaria | Celldex Therapeutics | Completed | Met primary |
| Phase 1 | NCT04538794 | Sep 2020 → Jan 2023 | chronic idiopathic urticaria | Celldex Therapeutics | Completed | Met primary |
| Phase 1 | NCT04146129 | Oct 2019 → Apr 2020 | — | Celldex Therapeutics | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT06727552 | Dec 2024 → May 2026 overdue | atopic eczema | Celldex Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06366750 | Apr 2024 → Jun 2026 overdue | prurigo nodularis | Celldex Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05405660 | Jun 2022 → Jun 2024 | chronic inducible urticaria | Celldex Therapeutics | Completed | Met primary |
| Phase 2 | NCT05368285 | May 2022 → Sep 2023 | chronic idiopathic urticaria | Celldex Therapeutics | Completed | Met primary |
| Phase 34 trials | ||||||
| Phase 3 | NCT07266402 | Jan 2026 → Jun 2028 expected | chronic inducible urticaria, cold urticaria | Celldex Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT07256392 | Nov 2025 → Sep 2028 expected | chronic idiopathic urticaria | Celldex Therapeutics | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06455202 | Jul 2024 → Oct 2026 expected | chronic idiopathic urticaria | Celldex Therapeutics | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06445023 | Jul 2024 → Oct 2026 expected | chronic idiopathic urticaria | Celldex Therapeutics | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT05774184 Comparator | Jun 2023 → Jun 2025 | eosinophilic esophagitis | Celldex Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2026-07-21 | Celldex Therapeutics | Results Celldex Reports Results from Phase 2 Study of Barzolvolimab in Prurigo Nodularis celldex.com ↗ |
| 2026-06-14 | Celldex Therapeutics | Results Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU at the European Academy of Allergy and Clinical Immunology Annual Meeting celldex.com ↗
The data presented demonstrated that barzolvolimab treatment results in rapid, significant, and durable improvements in angioedema in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines. |
| 2026-03-27 | Celldex Therapeutics | Results Celldex Presents Positive Data from Phase 2 Chronic Spontaneous Urticaria and Phase 2 Cold Urticaria and Symptomatic Dermographism Studies Demonstrating Rapid, Profound and Durable Improvements in Patient Quality of Life at AAD 2026 celldex.com ↗ |
| 2026-03-01 | Celldex Therapeutics | Results Celldex Presents Positive Data Demonstrating Barzolvolimab Retreatment Achieves Similar Profound Efficacy to First Exposure in Patients with Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) Further Demonstrating First-in-Class and Best-in-Disease Barzolvolimab Profile at AAAAI 2026 celldex.com ↗
Celldex (NASDAQ:CLDX) presented new positive data from the Phase 2 ColdU and SD Open Label Extension (OLE), highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence. |
| 2026-02-27 | Celldex Therapeutics | Results Celldex Presents Additional Positive Data from Phase 2 Chronic Spontaneous Urticaria (CSU) and Phase 2 Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) Studies Further Demonstrating First-in-Class and Best-in-Disease Barzolvolimab Profile at AAAAI 2026 celldex.com ↗
Celldex (NASDAQ:CLDX) presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD). |
| 2026-02-23 | Celldex Therapeutics | Results Celldex Announces Multiple Upcoming Presentations at AAAAI 2026 Supporting Barzolvolimab’s First-in-Class and Best-in-Disease Profile celldex.com ↗
New data from the Phase 2 ColdU and SD Open Label Extension (OLE) will be presented as a late breaker, highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence. |
| 2025-11-06 | Celldex Therapeutics | Results Celldex Presents Results from Barzolvolimab Phase 2 Study in Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) Demonstrating Sustained Efficacy and Favorable Safety Profile over 20 Week Placebo Controlled Treatment Period; Up to 66% of Patients with ColdU and 49% with SD Obtain Complete Response at Week 20 celldex.com ↗
Celldex (NASDAQ:CLDX) announced today new data demonstrating sustained efficacy and a well tolerated safety profile over a 20 week treatment period for barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). |
| 2025-11-06 | Celldex Therapeutics | Results Celldex Presents Additional Positive Data Demonstrating Barzolvolimab’s Ability to Drive Rapid, Profound and Durable Complete Urticaria Control in Phase 2 Chronic Spontaneous Urticaria (CSU) Study celldex.com ↗
Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). |
| 2025-09-17 | Celldex Therapeutics | Results Celldex Presents Data Demonstrating Barzolvolimab Improves Chronic Spontaneous Urticaria Independent of Baseline Immunoglobulin E levels in Phase 2 Study at EADV Congress 2025 celldex.com ↗ |
| 2025-08-19 | Celldex Therapeutics | Results Celldex Reports Results from Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis (EoE) celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported topline results from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. |
| 2025-06-14 | Celldex Therapeutics | Results Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025 celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). |
| 2025-06-12 | Celldex Therapeutics | Results Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025 celldex.com ↗
Celldex (NASDAQ:CLDX) announced today new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. |
| 2025-05-05 | Celldex Therapeutics | Results Celldex Presents Histology Data from Phase 2 Study of Barzolvolimab in EoE Supporting Potential of Mast Depleting Agent in this Difficult to Treat Disease celldex.com ↗
Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. |
| 2025-03-01 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Results from Barzolvolimab Phase 2 Studies in Patients with Chronic Urticaria Demonstrating Improved Disease Control and Quality of Life at AAAAI 2025 celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive data on measurements of disease control and quality of life from the Company’s Phase 2 barzolvolimab studies in patients with chronic urticaria. |
| 2024-10-26 | Celldex Therapeutics | Results Celldex Announces Barzolvolimab Met All Primary and Secondary Endpoints with High Statistical Significance in Positive Phase 2 Study in Chronic Inducible Urticaria celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). |
| 2024-09-25 | Celldex Therapeutics | Results Celldex Therapeutics Presents Landmark 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV 2024 celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new data demonstrating sustained and deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period for barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. |
| 2024-07-29 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). |
| 2024-06-02 | Celldex Therapeutics | Results Celldex Therapeutics Presents Data Demonstrating Profound Improvements in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2024 celldex.com ↗ |
| 2024-02-24 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. |
| 2023-11-06 | Celldex Therapeutics | Results Celldex Therapeutics Announces Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients who received prior biologics. |
| 2023-11-05 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Data from Prurigo Nodularis Phase 1b Study Demonstrating Meaningful Reduction in Itch and Skin Clearing with Single Dose 3.0 mg/kg Barzolvolimab celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data from the Company’s Phase 1b study of barzolvolimab in prurigo nodularis (PN). |
| 2023-06-10 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Data from Barzolvolimab Chronic Urticaria Program at EAACI 2023 celldex.com ↗
At week 24, 55% of all patients with CSU in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response (UAS7) and 69% had well-controlled disease (UCT) |
| 2023-02-26 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at AAAAI 2023 celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today updated data from the Company’s Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. |
| 2022-12-06 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Data from Barzolvolimab Phase 1b Study in Chronic Inducible Urticaria at Global Urticaria Forum 2022 celldex.com ↗
All 9 of 9 (100%) cold urticaria patients who received a 1.5 mg/kg single full dose of barzolvolimab experienced a complete response as assessed by provocation testing, including 4 of 4 patients with omalizumab refractory disease. |
| 2022-06-30 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022 celldex.com ↗
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced interim data from the Company’s ongoing Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. |
| 2021-09-29 | Celldex Therapeutics | Results Celldex Presents Positive Data on Symptom Control and Quality of Life Measurements that Further Support CDX-0159 Clinical Benefit in Phase 1b Study in Chronic Inducible Urticaria at EADV 2021 celldex.com ↗
A single dose of CDX-0159 (3 mg/kg) resulted in a rapid and sustained improvement in urticaria control and greatly reduced disease impact on quality of life, as measured by the Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI). |
| 2021-07-09 | Celldex Therapeutics | Results Celldex Therapeutics Presents Positive Data from CDX-0159 Phase 1b Study in Chronic Inducible Urticaria at EAACI 2021 celldex.com ↗
All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing. |
| 2021-03-29 | Celldex Therapeutics | Results Celldex Reports 80% Complete Response Rate in Interim Data Update from Phase 1b study of CDX-0159 in Chronic Inducible Urticaria celldex.com ↗
In all patients treated and assessed for at least 15 days after treatment (n=10), 8 of 10 patients (80%) experienced a complete response (CR) to provocation testing post-treatment and one patient experienced a partial response (PR). |
| 2021-03-29 | Celldex Therapeutics | Results Celldex Provides Corporate Update and Reports Fourth Quarter and Year End 2020 Results celldex.com ↗
These data support the novel mechanism of CDX-0159 and the potential broad applicability of this compound in mast cell driven diseases. |
| 2020-06-06 | Celldex Therapeutics | Results Celldex’s KIT Inhibitor CDX-0159 Demonstrates Profound, Sustained Dose-dependent Reductions in Plasma Tryptase—an Indicator of Mast Cell Burden—and a Favorable Safety Profile celldex.com ↗
CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression. |
All press releases naming this drug 57 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Barzolvolimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07266402 ↗ |
| Known as | CDX-0159 | “This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of barzolvolimab (CDX-0159) in adult...” NCT06727552 ↗7“The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.” NCT06366750 ↗ “Barzolvolimab (CDX-0159)” NCT05774184 ↗ |
| Action | Deplete | “mast cell-depleting anti-KIT antibody” PMID 41747871 ↗ Feb 2026 |
| Modality | Monoclonal antibody | “CDX-0159 is a humanized monoclonal antibody” NCT04146129 ↗ |
| Route | Intravenous | “Administered intravenously” NCT04538794 ↗ |
| Target | KIT | “binds to a protein called KIT” NCT04146129 ↗ |