Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03907878
Other study ID # CQGE031C1301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 13, 2019
Est. completion date January 26, 2022

Study information

Verified date September 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH. This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.


Description:

This was a Phase III multi-center, open-label, single arm study. The study consisted of 3 distinct periods: Screening period (Day -28 to Day -14): Subjects who gave informed consent were assessed for eligibility during this period which lasted for up to 4 weeks. Treatment period (52 weeks): Subjects had site visits every 4 weeks during this period to receive study drug and complete on-site assessments. Post-treatment follow-up period (12 weeks): Subject had site visits every 4 weeks with the final visit occurring 16 weeks after the last treatment dose. No study treatment was given during the period. This study was designed to obtain safety data of QGE031 in 66 Japanese CSU patients.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date January 26, 2022
Est. primary completion date January 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Signed informed consent must be obtained prior to participation in the study - Male and female subjects = 18 years of age at the time of screening - CSU diagnosis for = 6 months - Diagnosis of CSU refractory to H1-AH at approved doses at the time of Baseline (Visit 110, Day 1), as defined by all of the following: - The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1 (Day -28 to Day -14) despite current use of non-sedating H1-AH (at locally approved doses) during this time period - UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during the 7 days prior to baseline (Visit 110, Day 1) - Subjects must be on H1-AH at only approved doses for treatment of CSU for starting at Visit 1 (Day -28 to Day -14) - Willing and able to complete a daily symptom electronic Diary (eDiary) for the duration of the study and adhere to the study visit schedules Key Exclusion Criteria: - History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes (i.e. to murine, chimeric, or human antibodies) - Subjects having a clearly defined, predominant trigger of their chronic urticaria (CU) (chronic inducible urticaria (CINDU)) including - urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria - Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency) - Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not enter treatment period and will not be allowed to rescreen - Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid (BP), dermatitis herpetiformis, senile pruritus, etc) - Prior exposure to ligelizumab - Any H2 antihistamine, Leukotriene Receptor Antagonist (LTRA) (montelukast or zafirlukast) or H1 antihistamines use at greater than approved dose after Visit 1 Other protocol-defined inclusion/exclusion criteria may apply.

Study Design


Intervention

Biological:
Ligelizumab
Liquid in vial

Locations

Country Name City State
Japan Novartis Investigative Site Hiroshima
Japan Novartis Investigative Site Ichikawa Chiba
Japan Novartis Investigative Site Itabashi-ku Tokyo
Japan Novartis Investigative Site Kobe-shi Hyogo
Japan Novartis Investigative Site Machida-city Tokyo
Japan Novartis Investigative Site Neyagawa Osaka
Japan Novartis Investigative Site Nishinomiya-city Hyogo
Japan Novartis Investigative Site Obihiro Hokkaido
Japan Novartis Investigative Site Sakai Osaka
Japan Novartis Investigative Site Yokohama Kanagawa
Japan Novartis Investigative Site Yokohama Kanagawa

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks)
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
64 weeks
Secondary UAS7 Change From Baseline Over Time Mean change from baseline in UAS7 score over time is assessed as absolute change from baseline of UAS7 by visit up to end of study.
The Urticaria Activity Score (UAS) is the sum of Hive Severity Score (HSS) and Itch Severiry Score (ISS).
The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement.
The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42. A negative change from baseline indicates improvement.
Baseline, Weeks 12, 24, 52, and 64
Secondary HSS7 Change From Baseline Over Time The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours):
0 (None)
(1-6 hives/12 hours)
(7-12 hives/12 hours)
(> 12 hives/12 hours)
A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.
Score range is 0-21; and a negative change indicates improvement.
Baseline, Weeks 12, 24, 52, and 64
Secondary ISS7 Change From Baseline Over Time The ISS has a scale of 0 (none) to 3 (severe):
0 None
Mild (minimal awareness, easily tolerated)
Moderate (definite awareness, bothersome but tolerable)
Severe (difficult to tolerate)
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. So the score range of ISS7 is 0-21; and a negative change from baseline indicates improvement.
Baseline, Weeks 12, 24, 52, and 64
Secondary Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time Assessed as the proportion of subjects achieving UAS7 = 0 over time.
The UAS7 has a possible range in score of 0-42, and its complete response (complete urticaria control) was defined as UAS7 = 0
Weeks 12, 24, 52, and 64
Secondary Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time The proportion of subjects achieving HSS7 = 0 (complete absence of hives) over time
The HSS has a scale of 0 (none) to 3 (> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement.
Weeks 12, 24, 52, and 64
Secondary Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement. Weeks 12, 24, 52, and 64
Secondary Change From Baseline in the Dermatology Life Quality Index (DLQI) Assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30:
0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life
A negative change indicates improvement.
Baseline, Weeks 12, 24, 52 and 64
Secondary Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study Percentage of participants who achieved DLQI = 0/1 by visit up to end of study, assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30:
0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life
A negative change indicates improvement.
Weeks 12, 24, 52, and 64
See also
  Status Clinical Trial Phase
Recruiting NCT06077773 - Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria Phase 2
Completed NCT04538794 - A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 1
Completed NCT01803763 - Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients Phase 2/Phase 3
Recruiting NCT05298215 - A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria Phase 2
Terminated NCT04612725 - A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) Phase 2
Terminated NCT05528861 - A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria Phase 2
Completed NCT04109313 - An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU Phase 2
Completed NCT03580356 - A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Phase 3
Completed NCT03580369 - A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines Phase 3
Completed NCT05030311 - A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines Phase 3
Recruiting NCT06162728 - Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU) Phase 1/Phase 2
Completed NCT05107115 - Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine Phase 2
Recruiting NCT06042478 - A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. Phase 3
Terminated NCT04159701 - A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria Phase 2
Completed NCT03749135 - Dupilumab in Chronic Spontaneous Urticaria Phase 2
Not yet recruiting NCT06396026 - A Study of Efficacy and Safety of TLL-018 in CSU Participants Phase 3
Completed NCT02649218 - A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients Phase 2
Active, not recruiting NCT05368285 - A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria Phase 2
Completed NCT05373355 - Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria. Phase 1
Not yet recruiting NCT06365879 - To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria Phase 3