A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.
This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Start Date25 Nov 2025

Sponsor / Collaborator

Celldex Therapeutics, Inc.

NCT06727552

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

Start Date18 Dec 2024

Sponsor / Collaborator

Celldex Therapeutics, Inc.

NCT06455202

/ Active, not recruitingPhase 3

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.

Start Date19 Jul 2024

Sponsor / Collaborator

Celldex Therapeutics, Inc.

100 Clinical Results associated with Barzolvolimab

100 Translational Medicine associated with Barzolvolimab

100 Patents (Medical) associated with Barzolvolimab

Literatures (Medical) associated with Barzolvolimab

01 Apr 2026·JOURNAL OF INVESTIGATIVE DERMATOLOGY

The Role of Mast Cells in the Pathophysiology of Chronic Prurigo

Review

Author: Butze, Monique ; Metz, Martin ; Pereira, Manuel P. ; Kolkhir, Pavel ; Vera Ayala, Carolina

Chronic prurigo (CPG) is a highly itchy skin condition with unclear pathophysiology. The promising therapeutic effects of the tyrosine kinase KIT antibody barzolvolimab in an early-stage clinical trial have highlighted the crucial role of mast cells in the pathophysiology of CPG. This review discusses the important bidirectional crosstalk between mast cells and skin nerves, inflammatory cells, keratinocytes, and fibroblasts for initiating and maintaining the itch signal in CPG. In addition, we review mast cell-targeted treatments in CPG and explore future directions.

01 Mar 2026·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Emerging IgE and non-IgE targeted therapies for chronic urticaria

Review

Author: Chhiba, Krishan D ; Saini, Sarbjit S

Chronic urticaria affects a significant percent of the global population and carries a higher burden of unmet medical need. Current standard-of-care includes antihistamines and omalizumab, but omalizumab is not effective in all patients and has not been found to induce long-term disease remission. This review evaluates the diverse therapeutic pipeline spanning IgE-based and non-IgE-based mast cell targeting strategies, including recent clinical data. The therapeutic landscape has expanded rapidly with multiple mechanisms under investigation. IgE-targeted approaches include omalizumab biosimilars, with CT-P39 having received Food and Drug Administration (FDA) approval. Dupilumab received FDA approval for antihistamine-refractory chronic spontaneous urticaria supporting the targeting of type 2 cytokines, interleukin-4, and interleukin-13, in this disease. Bruton's tyrosine kinase inhibitors have promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab demonstrates robust efficacy with sustained effects post-treatment. Finally, Janus kinase inhibitors, Mas-related G protein-coupled receptor X2 antagonists, and other novel mechanisms are advancing through clinical trials. Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (Bruton's tyrosine kinase inhibitor), THB001 (c-Kit inhibitor), EP262 (Mas-related G protein-coupled receptor X2 antagonist), tezepelumab (anti-TSLP), and lirentelimab and AK006 (sialic acid binding immunoglobulin-like lectin-targeting agents), these studies have informed many of the other positive studies. In summary, in the last year, we have seen the chronic urticaria pipeline mature with multiple phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant therapeutic gaps persist for omalizumab-refractory disease and chronic-inducible urticaria.

01 Feb 2026·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Randomized dose-finding study of anti-KIT barzolvolimab in patients with chronic spontaneous urticaria

Article

Author: Leflein, Jeffrey ; Mitha, Essack ; Peter, Jonny ; Metz, Martin ; Bernstein, Jonathan A ; Krasowska, Dorota ; Talreja, Neetu ; Paradise, Elsa ; Anderson, John ; Heath-Chiozzi, Margo ; Young, Diane ; Greenberg, Steven ; Gotua, Maia

BACKGROUND:

Chronic spontaneous urticaria (CSU) is characterized by wheals and/or angioedema without identifiable triggers. Mast cells play a pathogenic role in disease, but more evidence is needed to support their role in driving clinical manifestations.

OBJECTIVE:

We assessed the efficacy and safety of various dose regimens of barzolvolimab, a mast cell-depleting anti-KIT antibody, in patients with CSU.

METHODS:

Adults with antihistamine-refractory CSU (urticaria activity score over 7 days [UAS7] ≥ 16) in a phase 2 double-blind placebo-controlled trial were randomized 1:1:1:1 to receive barzolvolimab 75 mg every 4 weeks (n = 53); 150 mg every 4 weeks (n = 52); 300 mg every 8 weeks (n = 51); or placebo (n = 51). The primary end point was UAS7 change from baseline to week 12.

RESULTS:

There was significant improvement in mean (95% confidence interval) change from baseline to week 12 in UAS7 in barzolvolimab-treated patients compared to patients who received placebo (75 mg every 4 weeks: -6.60 [-10.71, -2.49] P = .0017; 150 mg every 4 weeks: -12.55 [-16.56, -8.55] P < .0001; 300 mg every 8 weeks: -13.41 [-17.47, -9.34] P < .0001). Clinical improvement was rapid and marked, with 22.9%, 51.1%, and 37.5% (75 mg, 150 mg, and 300 mg, respectively) of barzolvolimab-treated patients who experienced complete response (UAS7 = 0) versus 6.4% for placebo at 12 weeks. The disease of patients with and without prior omalizumab treatment responded similarly. All doses of barzolvolimab were well tolerated, with urticaria and hair color change as the most common adverse events in barzolvolimab-treated patients.

CONCLUSION:

This study provides evidence for the essential role of mast cells in the signs and symptoms of CSU. Barzolvolimab is a promising treatment for CSU.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov NCT05368285.

114

News (Medical) associated with Barzolvolimab

07 May 2026

·ir.celldex.com

Celldex Reports First Quarter Financial Results and Provides Corporate Update

Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling Phase 1 CDX-622 proof of mechanism study in asthma ongoing 2026 expected to deliver multiple key data readouts across the pipeline Raised $345 million in gross proceeds from a follow-on public offering, closed in April 2026 HAMPTON, N.J. , May 07, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "We began the year with a significant milestone - the early completion of enrollment in our Phase 3 CSU studies - and we have continued to build on that momentum over the quarter,” said Anthony Marucci , Co-founder, President and Chief Executive Officer of Celldex. “This spring, barzolvolimab was featured in five presentations at leading medical meetings, further reinforcing its potential as a first-in-class, best-in-disease therapy with the ability to transform the treatment landscape for patients in need of better options. This progress enabled the successful completion of a $345 million financing in early April, strengthening our balance sheet and supporting continued investments in our commercialization preparations and growing pipeline.” “As we look ahead, our focus remains on execution—driving strong enrollment across our Phase 3 study in ColdU and SD and advancing towards multiple important data readouts this year,” Mr. Marucci continued. “These include topline data from our Phase 3 barzolvolimab CSU studies, results from Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Chronic Urticarias Enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU)—demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027. In December 2025 , Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the recently completed Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks). Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD were presented at the 2026 AAAAI Annual Meeting ( February 27 – March 2 ) and the 2026 AAD Annual Meeting (March 27 – 31) further demonstrating a first-in-class and best-in-disease profile. Key highlights include: Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20 Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20 Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment Prurigo Nodularis and Atopic Dermatitis Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026. Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Enrollment is complete in the multi-part Phase 1 study in healthy volunteers. Positive data from the single ascending dose portion of the study was presented in October 2025 . Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. In January 2026 , we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated. First Quarter 2026 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $451.5 million compared to $518.6 million as of December 31, 2025 . The decrease was primarily driven by first quarter cash used in operating activities of $65.6 million . At March 31, 2026 , Celldex had 66.6 million shares outstanding. In April 2026 , the Company issued 11,896,750 shares of its common stock in an underwritten public offering, resulting in gross proceeds to the Company of $345.0 million . Revenues: Total revenue was $0.0 million in the first quarter of 2026, compared to $0.7 million for the comparable period in 2025. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University . R&D Expenses: Research and development (R&D) expenses were $73.0 million in the first quarter of 2026, compared to $52.6 million for the comparable period in 2025. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $11.4 million in the first quarter of 2026, compared to $10.8 million for the comparable period in 2025. The increase in G&A expenses was primarily due to an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $78.7 million , or ( $1.18 ) per share, for the first quarter of 2026, compared to a net loss of $53.8 million , or ( $0.81 ) per share, for the comparable period in 2025. Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2026 , along with the approximately $323.9 million in net proceeds from our April 2026 underwritten public offering, are sufficient to meet estimated working capital requirements and fund current planned operations through 2028. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking StatementThis release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration(508) 864-8337scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560ptill@meruadvisors.com Source: Celldex Therapeutics, Inc.

Phase 2Phase 3Phase 1Financial StatementClinical Result

13 Apr 2026

·allsci.com

EC gives adds pediatric indication for Sanofi/Regeneron’s Dupixent in chronic spontaneous urticaria

The European Commission has approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years, making it the first targeted medicine authorised for this pediatric age group in the EU. Sanofi and Regeneron Pharmaceuticals, which jointly develop dupilumab, said the decision extends an existing EU approval covering adults and adolescents aged 12 and older. The approval also marks the fourth indication in which Dupixent is now authorised for children under 12 years in the EU across chronic diseases driven in part by type 2 inflammation. The approval covers children who remain symptomatic despite histamine-1 antihistamine treatment and who are naïve to anti-immunoglobulin E therapy for CSU. Dosing is weight- and age-based: children aged two to five years receive 200 mg every four weeks if weighing 5 kg to under 15 kg, or 300 mg every four weeks if weighing 15 kg to under 30 kg, without an initial loading dose. In the US, a supplemental biologics license application for dupilumab in children aged two to 11 years with CSU has been accepted for review, the companies said. The EU decision draws on data from the LIBERTY-CUPID Phase III clinical study program. This included an extrapolation of efficacy data from two Phase III adult studies, Study A and Study C, which were replicate double-blind, placebo-controlled trials assessing dupilumab as add-on therapy to antihistamines in patients aged six and older naïve to anti-IgE therapy. Both studies measured change from baseline in the weekly urticaria activity score at Week 24 as the primary endpoint, a composite of itch and hive severity on a 0–42 scale. Dupilumab significantly reduced urticaria activity and increased the proportion of patients with well-controlled disease and complete response compared with placebo. Pharmacokinetic, safety, and efficacy data from CUPIDKids (NCT05526521), a single-arm Phase III study in children aged two to 11 years, complemented the adult extrapolation. The primary endpoint in CUPIDKids was serum dupilumab concentration over time. Safety findings across all three studies were consistent with dupilumab’s established profile in dermatological indications; the most common adverse reactions included injection site reactions, conjunctivitis, and eosinophilia. CSU is a chronic inflammatory skin condition in which mast cell activation drives unpredictable episodes of hives and itch. Standard first-line treatment relies on H1 antihistamines, but a substantial proportion of patients remain symptomatic despite antihistamine use, leaving limited alternatives — particularly in young children, where therapeutic options have historically been constrained. Dupilumab inhibits signalling of interleukin-4 and interleukin-13, two cytokines central to type 2 inflammation, and is not classified as an immunosuppressant. The CSU pipeline for adults has grown considerably more crowded. Celldex Therapeutics is advancing barzolvolimab, an anti-KIT monoclonal antibody that depletes mast cells, through Phase III HARBOR trials. Novartis is running Phase III studies with remibrutinib, an oral BTK inhibitor, in the REMIX-1 and REMIX-2 trials. Sanofi itself is also developing rilzabrutinib, a BTK inhibitor, in Phase II/III for CSU, alongside its approved dupilumab programme. The pediatric segment, however, currently has no other approved targeted therapy, leaving dupilumab without direct competition in this age group for now. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Drug ApprovalClinical Result

06 Apr 2026

·allsci.com

Celldex Therapeutics raises USD 345m in stock offering

US-based Celldex Therapeutics, Inc. (Nasdaq: CLDX) announced the closing of an underwritten public offering of common stock, raising USD 345 million in gross proceeds to fund the continued clinical and preclinical development of its antibody-based pipeline targeting mast cell biology and inflammatory disease pathways. The offering comprised 11,896,750 shares of common stock priced at USD 29.00 per share, with all shares sold by Celldex. The total share count includes the full exercise by the underwriters of their option to purchase an additional 1,551,750 shares, representing the standard 15% overallotment. No warrants were issued in connection with this transaction. Leerink Partners, TD Cowen, Guggenheim Securities, and Cantor served as joint bookrunning managers for the offering. LifeSci Capital and H.C. Wainwright & Co. acted as co-lead managers. Company overview and pipeline Celldex Therapeutics is a clinical-stage biotechnology company headquartered in Hampton, New Jersey, focused on the development of antibody-based therapeutics at the intersection of mast cell biology and immune modulation. Its pipeline addresses severe inflammatory, allergic, and autoimmune diseases. The lead asset is barzolvolimab (CDX-0159), a monoclonal antibody targeting KIT (CD117) currently the subject of multiple active clinical trials. Two Phase III studies focused on chronic spontaneous urticaria (CSU) are active but not recruiting, with a third Phase III trial, designated EMBARQ, currently recruiting. A Phase IIIb study is also recruiting in CSU. Two additional Phase II studies in atopic dermatitis and other allergy indications remain active. Phase II topline data for barzolvolimab in CSU were reported in the Journal of Allergy and Clinical Immunology in 2024. Earlier in the pipeline, CDX-622 is a bispecific antibody that achieves mast cell depletion via stem cell factor (SCF) starvation and neutralization of the alarmin thymic stromal lymphopoietin (TSLP). The molecule is being evaluated in two Phase I studies, for indications including asthma. CDX-585, which inhibits PD-1 and ILT4, is in a Phase I study for various malignancies. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 1Phase 2ADCPhase 3Immunotherapy

100 Deals associated with Barzolvolimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatographic urticaria	Phase 3	United States	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Germany	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Lithuania	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Poland	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	South Africa	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Spain	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	United Kingdom	Celldex Therapeutics, Inc.	15 Jan 2026
Chronic Urticaria	Phase 3	United States	Celldex Therapeutics, Inc.	11 Jul 2024
Chronic Urticaria	Phase 3	Argentina	Celldex Therapeutics, Inc.	11 Jul 2024
Chronic Urticaria	Phase 3	Belgium	Celldex Therapeutics, Inc.	11 Jul 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05368285 (AAD2026)	Phase 2	Chronic Urticaria	50	Barzolvolimab	njyizuuand(byufumazao) = cqdkhekpab jylvzxshal (dcqipwmtow ) View more	Positive	27 Mar 2026
NCT05405660 (AAD2026)	Phase 2	Chronic Urticaria	196	Barzolvolimab SC 300mg Q8W	lfxufjnirn(rqpgbtqbxf) = gebojftlye xrjtsicnly (smxikvvghc ) View more	Positive	27 Mar 2026
				Barzolvolimab SC 150mg Q4W	lfxufjnirn(rqpgbtqbxf) = ngcgoqfrue xrjtsicnly (smxikvvghc ) View more
NCT05405660 (AAAAI2026)	Phase 2	Chronic Urticaria	121	Barzolvolimab	qgkdlijvzd(cbkhylpvvt) = toqhrlmulw gwgkwnqzwl (urebhqpkjv ) View more	Positive	27 Feb 2026
NCT05368285 (AAAAI2026)	Phase 2	Chronic Urticaria	78	Barzolvolimab	wcientgavg(lctidywfni) = wdzucktrgt qjutfpnkye (evthopspgu ) View more	Positive	27 Feb 2026
NCT05368285 (Pubmed \| J Allergy Clin Immunol)	Phase 2	Chronic Urticaria	207	Barzolvolimab 75 mg Q4W	ycbtbwqfeh(yajiqjadoz) = tdpjnvthal qmcjnykcwg (mzpiiisktp, -10.71 to -2.49) View more	Positive	01 Feb 2026
				Barzolvolimab 150 mg Q4W	ycbtbwqfeh(yajiqjadoz) = bbpbzfxfxl qmcjnykcwg (mzpiiisktp, -16.56 to -8.55) View more
NCT05774184 (PipelineReview) Manual	Phase 2	Eosinophilic Esophagitis	65	BarzolvolimabBarzolvolimab 300mg Q4W	orssuwlfso(wfgwsosiub) = offcxtznar pklobpfqiy (nwoansyklb ) Met	Negative	20 Aug 2025
				Placebo	orssuwlfso(wfgwsosiub) = rnqwhjuwxq pklobpfqiy (nwoansyklb ) Met
NCT05368285 (GlobeNewswire) Manual	Phase 2	Chronic Urticaria \| Angioedema	-	Barzolvolimab 150 mg Q4W	kgrloklcrg(vywziqdsad) = qopkbjemkp zibuewmgde (tfbqbsofmu ) View more	Positive	14 Jun 2025
				Barzolvolimab 300 mg Q8W	kgrloklcrg(vywziqdsad) = dnoidjllbg zibuewmgde (tfbqbsofmu ) View more
Company_Website Manual	Phase 2	Chronic Urticaria	-	Barzolvolimab	hqcrwguhks(xbdogxgbzg) = tamqoufxiu lqhfqjwune (iewofgdxwk ) View more	Positive	01 Mar 2025
NCT05405660 (Company_Website) Manual	Phase 2	Chronic Urticaria	-	Barzolvolimab	hatqmobjpb(uxrdvinacp) = tffxbbjcdi mvnomapamm (hqjtbolybr ) View more	Positive	01 Mar 2025
				Barzolvolimab (patients with SD)	hatqmobjpb(uxrdvinacp) = ubjwdwfkce mvnomapamm (hqjtbolybr )
NCT05405660 (phase II, ACAAI2024)	Phase 2	Chronic Urticaria	196	Barzolvolimab 150 mg every 4 weeks	aeyahdjqll(bluqnebuxu) = with grade I to II neutropenia being the most common adverse events hgvbofdeww (ovxmuytvfs )	Positive	24 Oct 2024
				Barzolvolimab 300 mg every 8 weeks

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