CompletedNCT02161562OPTIMAUpdated Sep 13, 2018Results posted

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

A Phase 3 interventional study of omalizumab and omalizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Completed at 35 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 314
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 CIU/CSU treatments taken by the participant were documented. Any protocol-defined prohibited CIU/CSU 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 4:3 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 (i.e. Canada or Latin America), baseline presence/absence 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 (UAS7≤6) but did not relapse during the 8 weeks Study Treatment withdrawal period (UAS7\<16) 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 (UAS7≤6) but did not relapse during the 8 weeks Study Treatment withdrawal period (UAS7\<16) 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.

Conditions studied

Chronic Spontaneous Urticaria

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Keywords

chronic spontaneous urticaria, CSU, chronic idiopathic urticaria, CIU, hives, angioedema, itch

In context

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's enrollment of 314 is above the median of 61 across 174 interventional studies indexed under Urticaria.

Browse Urticaria studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Men or women at least 18 years of age at time of screening.
Having a diagnosis of CSU and the presence of symptoms for ≥6 months prior to the screening visit.
Presence of itch and hives for ≥6 consecutive weeks at any time prior to the screening visit despite concurrent use of non-sedating H1-antihistamine treatment
Patient must have been on an approved dose of non-sedating H1-antihistamine for CSU, and no other concomitant CSU treatment, for at least the 7 consecutive days immediately prior to the randomization visit and must document current use on the day of the randomization visit.

Key Exclusion Criteria:

Patients having a clearly defined underlying etiology for chronic urticaria other than CSU including the following urticarias: acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact
Patients with other skin disease associated with itch that could interfere with study outcomes and/or compromise the safety of the patient
Patients with evidence of parasitic infection
Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women,
Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment.
Patients who are unable or unwilling to comply with study procedures, attend scheduled study visits, complete questionnaires and daily diaries, or who may otherwise be unable to comply with the study requirements.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 314 participants (actual)

Study arms

Experimental
omalizumab 150mg
Participants received 150mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period (at 150mg or 300mg) may have been implemented based on protocol-defined assessment criteria.
Drug: omalizumab
Experimental
omalizumab 300mg
Participants received 300mg omalizumab every 4 weeks during the initial dosing phase (24 weeks). A second dosing period may have been implemented based on protocol-defined assessment criteria.
Drug: omalizumab

Interventions

Drugomalizumab
150mg omalizumab via sub-cutaneous injection once every 4 weeks
Drugomalizumab
300mg omalizumab via sub-cutaneous injection once every 4 weeks

What researchers measure

Primary outcomes

Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.
Time frame: Last 7 days of second dosing period, 44 weeks

Secondary outcomes

The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days prior to the second dosing period, and the last 7 days of the second dosing period. A negative change indicates improvement.
Time frame: 7 days prior to start of second dosing period and last 7 days of Second Dosing Period
Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.
Time frame: Last 7 days of the second dosing period
Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the time between end of initial dosing period to first occurence of UAS7 ≥ 16 will be evaluated.
Time frame: study drug withdrawal period, weeks 24 through 32
Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the initial dosing period and the last 7 days of the second dosing period. A negative change indicates improvement.
Time frame: last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36
The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7-day period prior to Baseline visit and the last 7 days prior to the week 24 visit of initial dosing period. A negative change from baseline indicates improvement.
Time frame: 7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period
Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days before Baseline and the last 7 days of the second dosing period.
Time frame: 7 days prior to Baseline visit, and last 7 days of second dosing period
The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from week 8 of initial dosing phase and week 8 of second dosing phase.
Time frame: Week 8 of initial dosing phase and week 8 of second dosing phase

Results

Posted Aug 8, 2018

Participant flow

Participant flow — Overall Study
Milestone	Omalizumab 150mg (A)	Omalizumab 300mg (B)
Started	178	136
Completed	152	119
Not completed	26	17
Withdrew: Withdrawal by subject	5	8
Withdrew: Protocol violation	9	4
Withdrew: Pregnancy	1	2
Withdrew: Lost to follow-up	3	1
Withdrew: Lack of efficacy	4	1
Withdrew: Adverse event	1	1
Withdrew: Participant moved back to home country	1	0
Withdrew: Withdrew due to being out of the country	1	0
Withdrew: Participant moved out of province	1	0

Outcome measures

PrimaryNumber of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)

The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.

Time frame:: Last 7 days of second dosing period, 44 weeks
Reported as:: Count of participants · Participants

Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)
Participants	All Retreatment (A2&B2)	Retreatment (A2)	Retreatment (B2)
Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)	43	10	33

SecondaryThe Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)

Time frame:: 7 days prior to start of second dosing period and last 7 days of Second Dosing Period
Reported as:: Mean · score on a scale

The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)
score on a scale	Step-up Treatment Group (A3)
The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)	-9.5 ± 10.54

SecondaryNumber of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)

Time frame:: Last 7 days of the second dosing period
Reported as:: Number · Participants

Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)
Participants	Step-up Treatment Group (A3)
Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)	59

SecondaryTime to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)

The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the time between end of initial dosing period to first occurence of UAS7 ≥ 16 will be evaluated.

Time frame:: study drug withdrawal period, weeks 24 through 32
Reported as:: Mean · Weeks

Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)
Weeks	All Retreatment (A2&B2)	Retreatment (A2)	Retreatment (B2)
Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)	4.7 ± 2.37	4.8 ± 2.70	4.7 ± 2.31

SecondaryDifference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period

Time frame:: last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36
Reported as:: Mean · score on a scale

Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period
score on a scale	Extended Treatment (B3)
Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period	-2.0 ± 10.50

SecondaryThe Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants

Time frame:: 7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period
Reported as:: Mean · score on a scale

The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants
score on a scale	Omalizumab 300mg (B)
The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants	-23.8 ± 10.08

SecondaryChange in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period

Time frame:: 7 days prior to Baseline visit, and last 7 days of second dosing period
Reported as:: Mean · score on a scale

Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period
score on a scale	Omalizumab 150mg (A)	Omalizumab 300mg (B)	Overall (A&B)
Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period	-18.7 ± 11.66	-23.0 ± 10.92	-20.6 ± 11.53

SecondaryThe Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8

Time frame:: Week 8 of initial dosing phase and week 8 of second dosing phase
Reported as:: Number · Participants

The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8
Participants	All Retreatment (A2&B2)	Retreatment (A2)	Retreatment (B2)
UAS7<=6 at week 8 of the initial dosing period	43	12	31
UAS7=0 at week 8 of the initial dosing period	34	10	24
UAS7<=6 at week 8 of the second dosing period	36	9	27
UAS7=0 at week 8 of the second dosing period	23	5	18

Adverse events

Non-serious events are listed at a 0.0001% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Omalizumab 150 mg (A)	—	2/178 (1.1%)	119/178 (66.9%)
Maintained Response (A1)	—	0/15 (0%)	9/15 (60%)
Retreatment (A2)	—	0/12 (0%)	10/12 (83.3%)
Step-up Treatment Group (A3)	—	2/141 (1.4%)	94/141 (66.7%)
Omalizumab 300 mg (B)	—	6/136 (4.4%)	109/136 (80.1%)
Maintained Response(B1)	—	2/44 (4.5%)	32/44 (72.7%)
Retreatment (B2)	—	2/44 (4.5%)	37/44 (84.1%)
Extended Treatment (B3)	—	1/43 (2.3%)	37/43 (86%)

Most frequent serious events

Most frequent serious events
Event	Omalizumab 150 mg (A)	Maintained Response (A1)	Retreatment (A2)	Step-up Treatment Group (A3)	Omalizumab 300 mg (B)	Maintained Response(B1)	Retreatment (B2)	Extended Treatment (B3)
Porphyria acuteCongenital, familial and genetic disorders	0/178	0/15	0/12	0/141	1/136	0/44	0/44	1/43
Cardiac failureCardiac disorders	0/178	0/15	0/12	0/141	1/136	1/44	0/44	0/43
Maternal exposure during pregnancyInjury, poisoning and procedural complications	1/178	0/15	0/12	1/141	2/136	0/44	1/44	0/43
Pelvic fractureInjury, poisoning and procedural complications	0/178	0/15	0/12	0/141	1/136	0/44	1/44	0/43
Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/178	0/15	0/12	0/141	1/136	1/44	0/44	0/43
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/178	0/15	0/12	0/141	1/136	0/44	1/44	0/43
Cholecystitis chronicHepatobiliary disorders	1/178	0/15	0/12	1/141	0/136	0/44	0/44	0/43

Most frequent other events

Showing 10 of 284

Most frequent other events
Event	Omalizumab 150 mg (A)	Maintained Response (A1)	Retreatment (A2)	Step-up Treatment Group (A3)	Omalizumab 300 mg (B)	Maintained Response(B1)	Retreatment (B2)	Extended Treatment (B3)
NasopharyngitisInfections and infestations	29/178	3/15	3/12	20/141	24/136	5/44	10/44	8/43
CoughRespiratory, thoracic and mediastinal disorders	9/178	2/15	3/12	4/141	6/136	3/44	1/44	2/43
HeadacheNervous system disorders	23/178	2/15	2/12	18/141	19/136	5/44	5/44	9/43
Upper respiratory tract infectionInfections and infestations	9/178	2/15	2/12	5/141	15/136	4/44	8/44	2/43
Oedema peripheralGeneral disorders	5/178	2/15	0/12	3/141	2/136	0/44	2/44	0/43
NauseaGastrointestinal disorders	9/178	1/15	0/12	8/141	8/136	2/44	1/44	5/43
UrticariaSkin and subcutaneous tissue disorders	9/178	0/15	0/12	8/141	11/136	3/44	3/44	5/43
Back painMusculoskeletal and connective tissue disorders	7/178	1/15	1/12	5/141	7/136	2/44	1/44	4/43
RhinitisInfections and infestations	3/178	0/15	1/12	2/141	5/136	1/44	4/44	0/43
SinusitisInfections and infestations	10/178	1/15	1/12	8/141	6/136	4/44	1/44	1/43

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Omalizumab 150mg (A)	Omalizumab 300mg (B)	Total
Mean	46.7 ± 14.03	45.8 ± 13.60	46.3 ± 13.83

Sex: Female, Male
Sex: Female, Male(Participants)	Omalizumab 150mg (A)	Omalizumab 300mg (B)	Total
Female	130	99	229
Male	48	37	85

Study locations

35 sites

Novartis Investigative Site
Pilar, Buenos Aires 1629, Argentina
Novartis Investigative Site
Santa Fe, Rosario S2000DBS, Argentina
Novartis Investigative Site
Rosario, Santa Fe S2000CXH, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Salta, A4400ERH, Argentina
Novartis Investigative Site
Salvador, BA 40110-060, Brazil
Novartis Investigative Site
Rio de Janeiro, RJ 21941-913, Brazil
Novartis Investigative Site
Alphaville / Barueri, Sao Paulo 06454-010, Brazil
Novartis Investigative Site
Santo Andre, SP 09060-650, Brazil
Novartis Investigative Site
Edmonton, Alberta T5K 1X3, Canada
Novartis Investigative Site
Vancouver, British Columbia V5Z 4E8, Canada
Novartis Investigative Site
Vancouver, British Columbia V6H 3K2, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador A1A 4Y3, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador A1C 2H5, Canada
Novartis Investigative Site
Halifax, Nova Scotia B3J 3R4, Canada
Novartis Investigative Site
Barrie, Ontario L4M 6L2, Canada
Novartis Investigative Site
Hamilton, Ontario L8N 3Z5, Canada
Novartis Investigative Site
Hamilton, Ontario L8S 1G5, Canada
Novartis Investigative Site
Kingston, Ontario K7L 2V7, Canada
Novartis Investigative Site
Markham, Ontario L3P 1A8, Canada
Novartis Investigative Site
Ottawa, Ontario K1Y 4G2, Canada
Novartis Investigative Site
Peterborough, Ontario K9J 5K2, Canada
Novartis Investigative Site
Toronto, Ontario M4V 1R2, Canada
Novartis Investigative Site
Toronto, Ontario M5G 1E2, Canada
Novartis Investigative Site
Waterloo, Ontario N2J 1C4, Canada
Novartis Investigative Site
Windsor, Ontario N8X 2G1, Canada
Novartis Investigative Site
Quebec, GIV 4M6, Canada
Novartis Investigative Site
Toronto, M4C 5M5, Canada
Novartis Investigative Site
Santiago, 8207257, Chile
Novartis Investigative Site
Santiago, 8420383, Chile
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Guatemala City, 01015, Guatemala
Novartis Investigative Site
Delegacion Tlalpan, Distrito Federal 14050, Mexico
Novartis Investigative Site
Zapopan, Jalisco 45190, Mexico
Novartis Investigative Site
Panama, Panama

References and documents

Publications

Sussman G, Hebert J, Gulliver W, Lynde C, Yang WH, Papp K, Gooderham M, Chambenoit O, Khalil S, DeTakacsy F, Vieira A, Rihakova L. Omalizumab Re-Treatment and Step-Up in Patients with Chronic Spontaneous Urticaria: OPTIMA Trial. J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2372-2378.e5. doi: 10.1016/j.jaip.2020.03.022. Epub 2020 Apr 6. PubMed 32272284 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02161562
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 11, 2014
Start date: Aug 1, 2014
Primary completion: Nov 3, 2016
Completion: Nov 3, 2016
Results posted: Aug 8, 2018
Last update: Sep 13, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Urticaria→

Other studies from this sponsor

Novartis Pharmaceuticals

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