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

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ClinicalTrials.gov Identifier: NCT02161562
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : August 8, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: omalizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in CSU Patients
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : November 3, 2016
Actual Study Completion Date : November 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arm Intervention/treatment
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
150mg omalizumab via sub-cutaneous injection once every 4 weeks

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




Primary Outcome Measures :
  1. 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) [ Time Frame: Last 7 days of second dosing period, 44 weeks ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: 7 days prior to start of second dosing period and last 7 days 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 prior to the second dosing period, and the last 7 days of the second dosing period. A negative change indicates improvement.

  2. 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) [ Time Frame: Last 7 days of the 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 last 7 days of the second dosing period.

  3. 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) [ Time Frame: study drug withdrawal period, weeks 24 through 32 ]
    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.

  4. 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 [ Time Frame: last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36 ]
    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.

  5. The 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 ]
    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.

  6. Change 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 ]
    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.

  7. 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 [ Time Frame: Week 8 of initial dosing phase and week 8 of second dosing phase ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02161562


Locations
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Argentina
Novartis Investigative Site
Pilar, Buenos Aires, Argentina, 1629
Novartis Investigative Site
Santa Fe, Rosario, Argentina, S2000DBS
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000CXH
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site
Salta, Argentina, A4400ERH
Brazil
Novartis Investigative Site
Salvador, BA, Brazil, 40110-060
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site
Alphaville / Barueri, Sao Paulo, Brazil, 06454-010
Novartis Investigative Site
Santo Andre, SP, Brazil, 09060-650
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E8
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6H 3K2
Canada, Newfoundland and Labrador
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3J 3R4
Canada, Ontario
Novartis Investigative Site
Barrie, Ontario, Canada, L4M 6L2
Novartis Investigative Site
Hamilton, Ontario, Canada, L8N 3Z5
Novartis Investigative Site
Hamilton, Ontario, Canada, L8S 1G5
Novartis Investigative Site
Kingston, Ontario, Canada, K7L 2V7
Novartis Investigative Site
Markham, Ontario, Canada, L3P 1A8
Novartis Investigative Site
Ottawa, Ontario, Canada, K1Y 4G2
Novartis Investigative Site
Peterborough, Ontario, Canada, K9J 5K2
Novartis Investigative Site
Toronto, Ontario, Canada, M4V 1R2
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1E2
Novartis Investigative Site
Waterloo, Ontario, Canada, N2J 1C4
Novartis Investigative Site
Windsor, Ontario, Canada, N8X 2G1
Canada
Novartis Investigative Site
Quebec, Canada, GIV 4M6
Novartis Investigative Site
Toronto, Canada, M4C 5M5
Chile
Novartis Investigative Site
Santiago, Chile, 8207257
Novartis Investigative Site
Santiago, Chile, 8420383
Dominican Republic
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Guatemala
Novartis Investigative Site
Guatemala City, Guatemala, 01015
Mexico
Novartis Investigative Site
Delegacion Tlalpan, Distrito Federal, Mexico, 14050
Novartis Investigative Site
Zapopan, Jalisco, Mexico, 45190
Panama
Novartis Investigative Site
Panama, Panama
Sponsors and Collaborators
Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02161562    
Other Study ID Numbers: CIGE025ECA01
First Posted: June 11, 2014    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: September 13, 2018
Last Verified: August 2018
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
chronic spontaneous urticaria, CSU, chronic idiopathic urticaria, CIU, hives, angioedema, itch
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs