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Trial record 1 of 4 for:    Inducible Urticaria, Chronic
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Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines (PEARL-PROVOKE)

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ClinicalTrials.gov Identifier: NCT05024058
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is 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

Condition or disease Intervention/treatment Phase
Chronic Inducible Urticaria Drug: Ligelizumab Other: Placebo Phase 3

Detailed Description:
There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study is to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : August 5, 2024
Estimated Study Completion Date : December 27, 2024


Arm Intervention/treatment
Experimental: Ligelizumab low dose, symptomatic dermographism group
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Drug: Ligelizumab
Ligelizumab treated groups and arms
Other Name: QGE031

Experimental: Ligelizumab high dose, symptomatic dermographism
Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Drug: Ligelizumab
Ligelizumab treated groups and arms
Other Name: QGE031

Placebo Comparator: Placebo SC q4W, symptomatic dermographism
Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism
Other: Placebo
Placebo treated groups and arms

Experimental: Ligelizumab low dose, cold urticaria
Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria
Drug: Ligelizumab
Ligelizumab treated groups and arms
Other Name: QGE031

Experimental: Ligelizumab high dose, cold urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria
Drug: Ligelizumab
Ligelizumab treated groups and arms
Other Name: QGE031

Placebo Comparator: Placebo SC q4w, cold urticaria
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria
Other: Placebo
Placebo treated groups and arms

Experimental: Ligelizumab high dose, cholinergic urticaria
Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Drug: Ligelizumab
Ligelizumab treated groups and arms
Other Name: QGE031

Placebo Comparator: Placebo SC q4w, cholinergic urticaria
Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria
Other: Placebo
Placebo treated groups and arms




Primary Outcome Measures :
  1. Change from baseline in Total Fric Score in participants with symptomatic dermographism [ Time Frame: Week 12 ]
    Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)

  2. Change from baseline in critical temperature threshold in participants with cold urticaria [ Time Frame: Week 12 ]
    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.

  3. Change from baseline in itch numerical rating scale in participants with cholinergic urticaria [ Time Frame: Week 12 ]
    Itch numerical rating scale, a scale from 0 to 10


Secondary Outcome Measures :
  1. Proportion of participants with symptomatic dermographism with Total Fric score = 0 [ Time Frame: Week 12 ]
    Total Fric score, a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1

  2. Change from baseline in itch numerical rating scale in participants with symptomatic dermographism [ Time Frame: Week 12 ]
    Itch numerical rating scale, a scale from 0-10

  3. Proportion of participants with cold urticaria with complete response (no itch or hives) to the TempTest [ Time Frame: Week 12 ]
    The Temptest is used to induce itch and hives in participants with cold urticaria

  4. Change from baseline in itch numerical rating scale in participants with cold urticaria [ Time Frame: Week 12 ]
    Itch numerical rating scale, a scale from 0-10

  5. Proportion of participants with cholinergic urticaria with itch numerical rating scale =0 [ Time Frame: Week 12 ]
    Itch numerical rating scale, a scale from 0-10

  6. Proportion of participants with cholinergic urticaria with physician global assessment of severity of hives (PGA - hive score) =0 [ Time Frame: Week 12 ]
    Physician global assessment of severity of hives

  7. Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: Week 24 ]
    Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study
    • Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024058


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05024058    
Other Study ID Numbers: CQGE031E12301
2020-003018-11 ( EudraCT Number )
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
ligelizumab
anti-IgE
CINDU
chronic inducible urticaria
symptomatic dermographism
cold urticaria
cholinergic urticaria
urticaria
itch
hives
Additional relevant MeSH terms:
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Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases