Study of efficacy and safety of ligelizumab in chronic spontaneous urticariapatients who completed a previous study with ligelizumab
- Conditions
- Health Condition 1: L501- Idiopathic urticariaHealth Condition 2: L508- Other urticaria
- Registration Number
- CTRI/2020/09/027939
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Written informed consent must be obtained before any assessment is performed.
2. Subjectââ?¬•s, parentââ?¬•s or legal guardianââ?¬•s signed written informed consent and childââ?¬•s assent,
if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign
the corresponding study Informed Consent Form (ICF) at the next study visit.
3. Subjects who successfully completed all of the treatment period and the follow-up period
of any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or
CQGE031C1301.
a. Subjects who had completed the preceding studies prior to start of this extension study
are also allowed to participate, provided they perform the full Screening Period as soon
as the extension study had been initiated at their study site.
4. Male and female, adult and adolescent subjects �12 years of age (NOTE: Recruitment of
adolescent subjects, � 12 to < 18 years of age, will be in accordance with local
regulatory/ethics committee requirements).
5. Willing and able to complete a daily symptom eDiary for the duration of the study and
adhere to the study visit schedule.
6. Subjects must not have had any missing eDiary entries in the 7 days prior to the first visit
of the first half of the treatment period or first visit of the first observation period.
Rescreening may be considered only once.
1. Use of investigational drugs, other than those in use in the preceding studies, at the time of
enrollment, or within 30 days or 5 half-lives prior to Visit 1 (Screening visit), whichever is
longer.
2. Use of omalizumab within 16 weeks of Screening Visit 1
3. History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of
similar chemical classes (i.e. to murine, chimeric, or human antibodies).
4. New onset or signs and symptoms of any form of chronic urticarias other than CSU during
the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
5. Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis,
erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or
acquired angioedema (e.g., due to C1 inhibitor deficiency).
6. Subjects with evidence of helminthic parasitic infection as evidenced by stools being
positive for a pathogenic helminth according to local guidelines. All subjects should have
been assessed for evidence of parasitic infection at Visit 1999 of the preceding studies (see
Section 8.4.3 of respective preceding studyââ?¬•s protocol). If stool testing is positive for
pathogenic helminthic organisms, the subject will not be enrolled in to this extension study
and will not be allowed to rescreen.
7. Any other skin disease associated with chronic itching that might confound the study
evaluations and results (e.g. atopic dermatitis, contact dermatitis, bullous pemphigoid,
dermatitis herpetiformis, senile pruritus etc.).
8. Any H2-antihistamine use after Visit 1 in this study.
9. Any LTRA (e.g. montelukast or zafirlukast) use after Visit 1 in this study.
10. Any H1-antihistamine background medication used at greater than the local label approved
doses after Visit 1.
11. Prior exposure to any anti-IgE antibody therapy other than omalizumab and ligelizumab.
12. History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to
enrollment.
13. Inability to comply with study and follow-up procedures.
14. Subjects taking medications prohibited by the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of retreatment with ligelizumab 72 mg or 120 mg q4w in subjects previously treated in the core studies <br/ ><br>(CQGE031C2302/CQGE031C2303) <br/ ><br> <br/ ><br>To evaluate the efficacy of retreatment <br/ ><br>with ligelizumab in the subgroup of these <br/ ><br>subjects who achieved a weekly urticaria activity score (UAS7) � 6 after 12 weeks of treatment in these core studiesTimepoint: The proportion of subjects with well-controlled disease (UAS7 � 6) at Week 12
- Secondary Outcome Measures
Name Time Method