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

NCT05024058 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQGE031E123012020-003018-11
• Study Type: interventional
• Target: 39
• Locations: 9 countries
• Sites: 24

Brief Summary

This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines

Conditions

Chronic Inducible Urticaria

Keywords

ligelizumab; anti-IgE; CINDU; chronic inducible urticaria; symptomatic dermographism; cold urticaria; cholinergic urticaria; urticaria; itch; hives

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism

  Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed

  Baseline, Week 12

• Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria

  The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.

  Baseline, Week 12

• Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria

  Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")

  Baseline, Week 12

Secondary Outcomes (6)

• Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0

  Week 12

• Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism

  Baseline, Week 12

• Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest

  Baseline, Week 12

• Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria

  Baseline, Week 12

• Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0

  Week 12

Study Arms (8)

Ligelizumab low dose, symptomatic dermographism group

EXPERIMENTAL

Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Drug: Ligelizumab

Ligelizumab high dose, symptomatic dermographism

EXPERIMENTAL

Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Drug: Ligelizumab

Placebo SC q4W, symptomatic dermographism

PLACEBO COMPARATOR

Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism

Other: Placebo

Ligelizumab low dose, cold urticaria

EXPERIMENTAL

Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria

Drug: Ligelizumab

Ligelizumab high dose, cold urticaria

EXPERIMENTAL

Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria

Drug: Ligelizumab

Placebo SC q4w, cold urticaria

PLACEBO COMPARATOR

Placebo subcutaneous injection every 4 weeks in participants with cold urticaria

Other: Placebo

Ligelizumab high dose, cholinergic urticaria

EXPERIMENTAL

Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria

Drug: Ligelizumab

Placebo SC q4w, cholinergic urticaria

PLACEBO COMPARATOR

Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria

Other: Placebo

Interventions

Ligelizumab DRUG

Ligelizumab treated groups and arms

Also known as: QGE031

Ligelizumab high dose, cholinergic urticaria; Ligelizumab high dose, cold urticaria; Ligelizumab high dose, symptomatic dermographism; Ligelizumab low dose, cold urticaria; Ligelizumab low dose, symptomatic dermographism group

Placebo OTHER

Placebo treated groups and arms

Placebo SC q4W, symptomatic dermographism; Placebo SC q4w, cholinergic urticaria; Placebo SC q4w, cold urticaria

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.
• Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following:
• Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH
• Positive response (i.e. development of symptoms) to provocation test on day of randomization
• Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU.
• Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included.
• Willing and able to complete a daily symptom eDiary as per protocol requirement and adhere to the study visit schedules

You may not qualify if:

• History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
• Participants who have concomitant CSU at screening
• Diseases, other than chronic inducible urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
• Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism
• Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Novartis Investigative Site

Evansville, Indiana, 47713, United States

Location

Novartis Investigative Site

North Charleston, South Carolina, 29420, United States

Location

Novartis Investigative Site

El Paso, Texas, 79903, United States

Location

Novartis Investigative Site

Murray, Utah, 84107, United States

Location

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3002, Australia

Location

Novartis Investigative Site

Athens, 12462, Greece

Location

Novartis Investigative Site

Debrecen, Hajdú-Bihar, 4026, Hungary

Location

Novartis Investigative Site

Pécs, 7632, Hungary

Location

Novartis Investigative Site

Szeged, 6720, Hungary

Location

Novartis Investigative Site

Izhevsk, 426061, Russia

Location

Novartis Investigative Site

Rostov-on-Don, 344022, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194156, Russia

Location

Novartis Investigative Site

Saint Petersburg, 194354, Russia

Location

Novartis Investigative Site

Saint Petersburg, 198260, Russia

Location

Novartis Investigative Site

Stavropol, 355000, Russia

Location

Novartis Investigative Site

Kežmarok, 060 01, Slovakia

Location

Novartis Investigative Site

Svidník, 08901, Slovakia

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Ankara, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

Location

Related Links

• Patient Lay Trial Summary

MeSH Terms

Conditions

Chronic Inducible Urticaria; Familial dermographism; Cold Urticaria; Urticaria; Pruritus

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Chronic Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

(862) 778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: November 16, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: June 18, 2024
• Results First Posted: September 15, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

TW (1); AU (2); HU (3); US (4); ES (3); TU (2); GR (1); SL (2); RU (6)