Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02161562
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2014-06-10
Brief Title:
OPTIMA Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria CSU Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
OPTIMA Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in CSU Patients
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief Summary:
This trial assessed the efficacy of optimized re-treatment therapy with omalizumab 150mg or 300mg after relapse in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab 150mg or 300mg The study also assessed the benefit of uptitrating to 300mg dose in participants who were not well-controlled following their initial course of treatment with omalizumab 150mg as well as the benefit of treatment extension of those patients who were not well-controlled following their initial course of treatment with omalizumab 300mg
Detailed Description:
The study consisted of 5 phases
Phase 1 Screening At the first visit Screening Visit the participant was provided informed consent and then completed all screening visit assessments During this visit all CIUCSU treatments taken by the participant were documented Any protocol-defined prohibited CIUCSU treatments were stopped at this visit and the participant underwent a wash-out period of 1-5weeks refer to study protocol for medication wash-out times prior to Phase 2 Visit1 Only non-sedating H1- antihistamines at locally-approved dosages were allowed to be continued during the Screening Period and throughout the rest of the study All participants also needed to complete daily diary during the entire screening period
Phase 2 Initial Dosing Period Following completion of Phase 1 eligible participants were randomly assigned in a 43 ratio to either Group A or Group B Participants in Group A were treated with omalizumab 150mg by subcutaneous SC injection every 4 weeks during the 24-week Phase 2 Initial Dosing Period while participants in Group B were treated with omalizumab 300mg every 4 weeks during this period Randomization to treatment groups was stratified at Phase 2 Visit 1 by geographic location of the study site ie Canada or Latin America baseline presenceabsence of angioedema and baseline UAS7 score collected at Phase 2 Visit 1 At the end of Phase 2 all participants with a UAS7 score 6 entered Phase 3 Study Treatment Withdrawal Period Group A participants who had a UAS7 6 at any visit of Phase 2 starting at Week 8 Phase2-Visit3 skipped Phase 3 and moved directly to Phase 4 Second Dosing Period and received 300 mg Omalizumab step-up Group B participants who had a UAS7 6 at the end of Phase 2 skipped Phase 3 and moved directly to Phase 4
Phase 3 Study Treatment Withdrawal Period During Phase 3 Study Treatment Withdrawal Period no study treatment omalizumab was given and participants continued to visit the study center at 4-week intervals to a maximum of 8 weeks If a UAS7 score 16 was observed during Phase 3 Study Treatment Withdrawal Period the participant moved directly to Phase 4 Second Dosing Period If a participant completed the full 8 weeks of Phase 3 Study Treatment Withdrawal Period with a UAS7 score 16 the participant was moved directly to Phase 5 Follow-up Period
Phase 4 Second Dosing Period
Group A participants who relapsed UAS7 16 during Phase 3 Study Treatment Withdrawal Period were retreated with omalizumab 150mg by SC injection every 4 weeks during the 12-week Phase 4 Second Dosing Period
Group A participants who were not clinically well-controlled at week 8 of Phase 2 Initial Treatment Period or any subsequent visit in Phase 2 moved to Phase 4 Second Dosing Period immediately during which their study treatment was up-titrated to 300mg by SC injection every 4 weeks for 12 weeks
Group A participants who had their symptoms well controlled at week 24 UAS76 but did not relapse during the 8 weeks Study Treatment withdrawal period UAS716 moved directly to Phase 5 Follow up period
Group B participants who relapsed during Phase 3 Study Treatment Withdrawal Period were retreated with omalizumab 300mg by SC injection every 4 weeks during the 12- week Phase 4 Second Dosing Period
Group B participants who were not clinically well-controlled at week 24 of Phase 2 Initial Treatment Period moved to Phase 4 Second Dosing Period immediately during which their study treatment remained 300mg by SC injection every 4 weeks for 12 weeks In case the treating physician and the participant decided not to extend treatment they could move directly from Phase 2 Initial Treatment Period to Phase 5 Follow- up Period
Group B participants who had their symptoms well controlled at week 24 UAS76 but did not relapse during the 8 weeks Study Treatment withdrawal period UAS716 moved directly to Phase 5 Follow up period
Phase 5 Follow-up Period
Participants who did not relapse UAS7 16 following completion of Phase 3 Study Treatment Withdrawal Period entered the 4-week Phase 5 Follow-up Period
Group B participants who did not respond during their initial 24-week treatment period Phase 2 and who did not wish to extend their treatment into Phase 4 Second Dosing Phase were allowed to move directly into the 4-week Phase 5 Follow-up Period
All participants who completed Phase 4 Second Dosing Period entered the 4-week Phase 5 Follow-up Period
During Phase 5 Follow-up Period participants continued to only receive non-sedating H1- antihistamines at approved dosages Omalizumab was not allowed to be administered during this period
Phase 1 Screening At the first visit Screening Visit the participant was provided informed consent and then completed all screening visit assessments During this visit all CIUCSU treatments taken by the participant were documented Any protocol-defined prohibited CIUCSU treatments were stopped at this visit and the participant underwent a wash-out period of 1-5weeks refer to study protocol for medication wash-out times prior to Phase 2 Visit1 Only non-sedating H1- antihistamines at locally-approved dosages were allowed to be continued during the Screening Period and throughout the rest of the study All participants also needed to complete daily diary during the entire screening period
Phase 2 Initial Dosing Period Following completion of Phase 1 eligible participants were randomly assigned in a 43 ratio to either Group A or Group B Participants in Group A were treated with omalizumab 150mg by subcutaneous SC injection every 4 weeks during the 24-week Phase 2 Initial Dosing Period while participants in Group B were treated with omalizumab 300mg every 4 weeks during this period Randomization to treatment groups was stratified at Phase 2 Visit 1 by geographic location of the study site ie Canada or Latin America baseline presenceabsence of angioedema and baseline UAS7 score collected at Phase 2 Visit 1 At the end of Phase 2 all participants with a UAS7 score 6 entered Phase 3 Study Treatment Withdrawal Period Group A participants who had a UAS7 6 at any visit of Phase 2 starting at Week 8 Phase2-Visit3 skipped Phase 3 and moved directly to Phase 4 Second Dosing Period and received 300 mg Omalizumab step-up Group B participants who had a UAS7 6 at the end of Phase 2 skipped Phase 3 and moved directly to Phase 4
Phase 3 Study Treatment Withdrawal Period During Phase 3 Study Treatment Withdrawal Period no study treatment omalizumab was given and participants continued to visit the study center at 4-week intervals to a maximum of 8 weeks If a UAS7 score 16 was observed during Phase 3 Study Treatment Withdrawal Period the participant moved directly to Phase 4 Second Dosing Period If a participant completed the full 8 weeks of Phase 3 Study Treatment Withdrawal Period with a UAS7 score 16 the participant was moved directly to Phase 5 Follow-up Period
Phase 4 Second Dosing Period
Group A participants who relapsed UAS7 16 during Phase 3 Study Treatment Withdrawal Period were retreated with omalizumab 150mg by SC injection every 4 weeks during the 12-week Phase 4 Second Dosing Period
Group A participants who were not clinically well-controlled at week 8 of Phase 2 Initial Treatment Period or any subsequent visit in Phase 2 moved to Phase 4 Second Dosing Period immediately during which their study treatment was up-titrated to 300mg by SC injection every 4 weeks for 12 weeks
Group A participants who had their symptoms well controlled at week 24 UAS76 but did not relapse during the 8 weeks Study Treatment withdrawal period UAS716 moved directly to Phase 5 Follow up period
Group B participants who relapsed during Phase 3 Study Treatment Withdrawal Period were retreated with omalizumab 300mg by SC injection every 4 weeks during the 12- week Phase 4 Second Dosing Period
Group B participants who were not clinically well-controlled at week 24 of Phase 2 Initial Treatment Period moved to Phase 4 Second Dosing Period immediately during which their study treatment remained 300mg by SC injection every 4 weeks for 12 weeks In case the treating physician and the participant decided not to extend treatment they could move directly from Phase 2 Initial Treatment Period to Phase 5 Follow- up Period
Group B participants who had their symptoms well controlled at week 24 UAS76 but did not relapse during the 8 weeks Study Treatment withdrawal period UAS716 moved directly to Phase 5 Follow up period
Phase 5 Follow-up Period
Participants who did not relapse UAS7 16 following completion of Phase 3 Study Treatment Withdrawal Period entered the 4-week Phase 5 Follow-up Period
Group B participants who did not respond during their initial 24-week treatment period Phase 2 and who did not wish to extend their treatment into Phase 4 Second Dosing Phase were allowed to move directly into the 4-week Phase 5 Follow-up Period
All participants who completed Phase 4 Second Dosing Period entered the 4-week Phase 5 Follow-up Period
During Phase 5 Follow-up Period participants continued to only receive non-sedating H1- antihistamines at approved dosages Omalizumab was not allowed to be administered during this period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None