Living with chronic spontaneous urticaria, or hives, can be incredibly challenging, especially when standard treatments like antihistamines don’t provide relief. This study is exploring a new treatment called barzolvolimab for adults who continue to experience symptoms despite taking these medications. The study involves around 915 participants who will be randomly assigned to receive either barzolvolimab or a placebo, which is a treatment with no active ingredients. Over a 24-week period, researchers will closely monitor how well barzolvolimab works compared to the placebo. The main focus will be on measuring changes in the severity of hives over time. If barzolvolimab proves effective, it could be a game-changer for many people who feel stuck with their symptoms, offering a new option for managing this frustrating condition.
Phase 3 Study Evaluates Barzolvolimab for Chronic Spontaneous UrticariaCan a new treatment finally help those suffering from chronic hives?
AI-generated summary of the cited source, checked by automated accuracy review. How we work
Key Takeaway
Evaluate barzolvolimab's effectiveness in CSU unresponsive to antihistamines.
This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study investigates the efficacy, safety, and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. The study includes a screening period of up to 4 weeks, a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab, and a 16-week treatment-free period. The primary outcome is the mean change from baseline to Week 12 in the Urticaria Activity Score (UAS7). A total of 963 participants are enrolled, with 610 in the active arms and 305 in the placebo arm. The study is sponsored by Celldex Therapeutics, with a start date of July 11, 2024, and a primary completion date in October 2026.
What this means for you:
Barzolvolimab could be a new hope for adults struggling with chronic spontaneous urticaria. More on Chronic Spontaneous Urticaria
Systematic review links viral infections to persistent and chronic urticaria in children and adults
Viral infections may trigger hives that last months or turn chronic in some people
This systematic review of 596 participants examined the association between viral infections and infection-associated urticaria. Findings in…
A review of 596 patients found that viral infections can cause hives lasting months or progressing to a chronic condition in some cases.
Network meta-analysis of classical TCM formulas as adjuncts to antihistamines for chronic spontaneous urticaria
Chinese Herbs May Stop Hives From Coming Back
This network meta-analysis of 5,814 patients with chronic spontaneous urticaria synthesized evidence on classical TCM formulas as adjuncts t…
Combining traditional Chinese herbs with standard allergy medicine may help people with stubborn hives feel better sooner and keep the rash …
Retrospective case series evaluates omalizumab efficacy in Chinese pediatric chronic spontaneous urticaria patients
This Hives Medicine Might Help Young Children Finally Find Relief
This retrospective case series assessed omalizumab in 13 Chinese children under 12 years with chronic spontaneous urticaria.
A common hives drug shows promise for younger kids who usually have few options.
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3
Condition(s): Chronic Spontaneous Urticaria
Intervention(s): barzolvolimab (BIOLOGICAL), Matching placebo (BIOLOGICAL)
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.
Detailed: This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.
There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Primary Outcome(s): Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Enrollment: 963 (ACTUAL)
Lead Sponsor: Celldex Therapeutics
Start: 2024-07-11 | Primary Completion: 2026-10
Guselkumab Phase III trials validate 3VAS and 4VAS measures for psoriatic arthritis disease activity assessment
Study checks how well pain scores track joint damage in psoriatic arthritis patients
Related in Dermatology
Nemolizumab Q4W improves IGA success maintenance by 11.8% over withdrawal in atopic dermatitis
Trial shows nemolizumab maintains skin results for atopic dermatitis
This Phase 3 randomized controlled trial evaluated nemolizumab in 507 adolescents and adults with moderate-to-severe atopic dermatitis who w…
A new trial found that nemolizumab helps maintain clear skin and reduce itching for adults and teens with moderate to severe atopic dermatit…
SSGJ-608 achieves 92.7% to 95.1% PASI75 response in moderate-to-severe plaque psoriasis
New injection shows promise for moderate to severe plaque psoriasis
This phase 3 randomized trial in 770 patients with moderate-to-severe plaque psoriasis found that SSGJ-608 (80mg every 2 weeks or 160mg ever…
A new injectable treatment showed high success rates in clearing skin and improving appearance for people with plaque psoriasis.
Operating room nurses describe critical trauma management challenges and teamwork dynamics in a qualitative review
Nurses share how trauma care shapes their daily work and personal lives
Fifteen experienced trauma nurses shared their lived experiences managing critical multiple injuries in a tertiary Hunan hospital. Their nar…
Fifteen experienced nurses describe the professional challenges, teamwork dynamics, and stress they face while managing critical trauma case…
FDA Approves Tremfya (guselkumab) for Ulcerative Colitis and Crohn's Disease
FDA approves Tremfya for ulcerative colitis and Crohn's disease.
The FDA approved Tremfya (guselkumab) for adults with moderately to severely active ulcerative colitis and Crohn's disease. The approval exp…
The FDA approved Tremfya (guselkumab) for adults with moderate to severe ulcerative colitis or Crohn's disease. It is the first drug of its …
From Other Specialties
Rapid advancements in imaging and blood-based biomarkers are transforming the diagnosis and management of ADRD
New guidelines help doctors tell delirium from dementia
This clinical guideline provides a narrative review on the evolving diagnostic and treatment landscape for Alzheimer's disease and related d…
Delirium is acute and fluctuating; dementia is chronic. New guidelines help doctors tell them apart.
ACTH and vigabatrin achieved full seizure control in a patient with Ververi-Brady syndrome
ACTH and Vigabatrin Show Promise for Rare Epilepsy Syndrome
This case report describes a 5-month-old male infant with Ververi-Brady syndrome and infantile epileptic spasms syndrome. The patient achiev…
A new gene variant linked to Ververi-Brady syndrome showed positive results when treated with a combination of ACTH and vigabatrin.
Postoperative AKI occurs in half of type A aortic dissection surgeries, meta-analysis finds
Factors Linked to Kidney Injury After Aortic Dissection Surgery
This meta-analysis of 44 studies (11,983 patients) found that 50.72% of patients undergoing surgery for Stanford type A aortic dissection de…
Over half of patients undergoing surgery for a specific type of aortic dissection develop acute kidney injury, with several risk factors ide…
Social and emotional skills training shows non-significant reductions in loneliness among children and adolescents
Social and Emotional Training Shows Promise for Youth Loneliness
This meta-analysis of 18 studies evaluated interventions targeting loneliness, including social and emotional skills training, in youth aged…
New research looks at how social and emotional skills training can help reduce feelings of loneliness in children and teenagers.