Ligelizumab for Urticaria

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, East Melbourne, Australia
Urticaria+2 More
Ligelizumab - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

See full description

Eligible Conditions

  • Urticaria
  • Chronic Inducible Urticaria

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Urticaria

Study Objectives

This trial is evaluating whether Ligelizumab will improve 3 primary outcomes and 7 secondary outcomes in patients with Urticaria. Measurement will happen over the course of Week 12.

Week 12
Change from baseline in Total Fric Score in participants with symptomatic dermographism
Change from baseline in critical temperature threshold in participants with cold urticaria
Change from baseline in itch numerical rating scale in participants with cholinergic urticaria
Change from baseline in itch numerical rating scale in participants with cold urticaria
Change from baseline in itch numerical rating scale in participants with symptomatic dermographism
Proportion of participants with cholinergic urticaria with itch numerical rating scale =0
Proportion of participants with cholinergic urticaria with physician global assessment of severity of hives (PGA - hive score) =0
Proportion of participants with cold urticaria with complete response (no itch or hives) to the TempTest
Proportion of participants with symptomatic dermographism with Total Fric score = 0
Week 24
Occurrence of treatment emergent adverse events and serious adverse events during the study

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Urticaria

Side Effects for

Ligelizumab 120 mg
Nasopharyngitis
31%
Vomiting
23%
Nausea
23%
Upper respiratory tract infection
15%
Urinary tract infection
15%
Pyrexia
15%
Rhinitis
15%
Odynophagia
8%
Administration site erythema
8%
Urticaria
8%
Dysmenorrhoea
8%
Respiratory tract infection viral
8%
Abdominal pain upper
8%
Influenza
8%
Eye pruritus
8%
Migraine
8%
Arthropod bite
8%
Headache
8%
Pruritus
8%
Fibromyalgia
8%
Viral infection
8%
Dry skin
8%
Injection site pain
8%
Post procedural infection
8%
Pharyngitis
8%
Menstruation irregular
8%
Gastrointestinal infection
8%
Onycholysis
8%
Intercostal neuralgia
0%
Toothache
0%
Suicide attempt
0%
Gastritis
0%
Hyperbilirubinaemia
0%
Injection site reaction
0%
Abdominal pain
0%
Pulmonary valve incompetence
0%
Tricuspid valve incompetence
0%
Chronic spontaneous urticaria
0%
Face injury
0%
Back pain
0%
Injection site erythema
0%
Diarrhoea
0%
Muscle spasms
0%
Angioedema
0%
Epistaxis
0%
Animal bite
0%
Medial tibial stress syndrome
0%
Dizziness
0%
Arthralgia
0%
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03437278) in the Ligelizumab 120 mg ARM group. Side effects include: Nasopharyngitis with 31%, Vomiting with 23%, Nausea with 23%, Upper respiratory tract infection with 15%, Urinary tract infection with 15%.

Trial Design

8 Treatment Groups

Ligelizumab high dose, cold urticaria
1 of 8
Ligelizumab low dose, symptomatic dermographism group
1 of 8
Ligelizumab high dose, symptomatic dermographism
1 of 8
Ligelizumab low dose, cold urticaria
1 of 8
Ligelizumab high dose, cholinergic urticaria
1 of 8
Placebo SC q4W, symptomatic dermographism
1 of 8
Placebo SC q4w, cold urticaria
1 of 8
Placebo SC q4w, cholinergic urticaria
1 of 8
Experimental Treatment
Non-Treatment Group

This trial requires 428 total participants across 8 different treatment groups

This trial involves 8 different treatments. Ligelizumab is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Ligelizumab high dose, cold urticaria
Drug
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria
Ligelizumab low dose, symptomatic dermographism group
Drug
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Ligelizumab high dose, symptomatic dermographism
Drug
Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Ligelizumab low dose, cold urticaria
Drug
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria
Ligelizumab high dose, cholinergic urticaria
Drug
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Placebo SC q4W, symptomatic dermographism
Other
Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Placebo SC q4w, cold urticaria
Other
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
Placebo SC q4w, cholinergic urticaria
Other
Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ligelizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 24 for reporting.

Closest Location

Novartis Investigative Site - Boise, ID

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The test must be physically possible for the participant, and must be specific to their CINDU. show original
Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization show original
The subject had a positive response (i.e show original
The text confirms that the person has a CINDU diagnosis for a condition that causes symptoms such as dermatographism, cold urticaria, or cholinergic urticaria show original
I can complete a daily symptom diary and follow the study schedule. show original
antagonist indicates a diagnosis of spontaneous rhinitis If a person's symptoms worsen in spite of treatment with an H1-antihistamine, it is likely that they have spontaneous rhinitis. show original

Patient Q&A Section

What is urticaria?

"We propose that urticaria is an exaggerated release of histamine in response to various substances; this definition will allow clinicians to evaluate and treat this common condition with a straightforward, non-invasive approach.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of urticaria?

"U.T. may present with wheals, itch or other local or general symptoms; dermatological and systemic manifestations can also occur, although the dermatological or systemic presentation is more common." - Anonymous Online Contributor

Unverified Answer

What are common treatments for urticaria?

"Common treatment for urticaria includes avoidance of triggers, medications, antihistamines, mast cells inhibitors and anti-allergic medications. Antihistamine is often used alone as treatment for urticaria because its efficacy could not be found in controlled trials." - Anonymous Online Contributor

Unverified Answer

How many people get urticaria a year in the United States?

"Although there are significant differences in the frequency of urticaria by ethnic origin, ethnicity, gender and by region, approximately 18 million people per year are affected with urticaria in the United States. More studies have to be carried out to collect more precise data." - Anonymous Online Contributor

Unverified Answer

Can urticaria be cured?

"In children and young adults, hCG is used either only on occasion or for mild urticaria. As a first line treatment for hCG-induced urticaria, low doses of antihistamine may alleviate symptoms. If used for longer than 5 days, antihistamine should be tapered and reduced to low doses." - Anonymous Online Contributor

Unverified Answer

What causes urticaria?

"Although no one cause for urticaria has been definitively identified, environmental causes and drug reactions have been identified and it is likely that multiple causes are involved for the majority of patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ligelizumab for therapeutic use?

"In a recent study, findings suggest possible clinical application of ligelizumab for treatment of AHR or MHR, especially in patients refractory to therapy with a conventional first-line agent." - Anonymous Online Contributor

Unverified Answer

Has ligelizumab proven to be more effective than a placebo?

"In a recent study, findings demonstrated that the effectivity of anti-IL-13 agents, including ligelizumab, in allergic rhinitis does not outweigh the safety level in terms of adverse events. LIG has significantly lower occurrence of adverse events with a better safety profile than ARA." - Anonymous Online Contributor

Unverified Answer

Is ligelizumab typically used in combination with any other treatments?

"Results from a recent paper shows a low use of systemic treatment with immunomodulators, mostly used instead of corticosteroids, with the exclusion of patients on immunosuppressive treatment and patients with severe chronic urticaria. A systematic review of the current literature shows that patients treated with systemic immunosuppressive therapy are at high risk of developing serious infections." - Anonymous Online Contributor

Unverified Answer

Does ligelizumab improve quality of life for those with urticaria?

"Treatment with ligelizumab has shown to be effective in the treatment of patients with H1-receptor-positive urticaria. The improvement in health and health-related quality of life associated with treatment may be particularly important to patients when considering the burden of urticaria." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for urticaria?

"As the diagnosis rate for urticaria increased in the last few years, the number of patients attending a physician's office for management of urticaria has also increased. A significant proportion of these patients present with chronic urticaria. Although a minority have severe symptoms, they still require clinical assessment and an empirical treatment of chronic urticaria. Given the high risk of harm from uncontrolled trials of therapies or from an incorrect classification of patients on the basis of observational reports, clinicians need to consider clinical trials for these patients. Physicians can obtain funding for clinical trials for urticaria by contacting the ClinicalTrials.gov website." - Anonymous Online Contributor

Unverified Answer

How does ligelizumab work?

"Ligelizumab is effective for the treatment of persistent urticaria in the majority of patients with a high response rate. One major adverse event seen was a slight increase in liver enzymes. Data from a recent study support the notion that ligelizumab is effective for the treatment of persistent urticaria, which would be of relevance to patients with autoimmune hepatitis. ClinicalTrials.gov number: NCT00279899\nquestion: Is endothelin receptor antagonism as effective as cyclosporine. A review of the literature? answer: There is no substantial evidence to support a difference between cyclosporine and endothelin receptor antagonists in treating chronic graft dysfunction." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Urticaria by sharing your contact details with the study coordinator.