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

NCT02161562 | Completed Phase 3 Results

• 1 other identifier: CIGE025ECA01
• Study Type: interventional
• Target: 314
• Locations: 8 countries
• Sites: 35

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.

Conditions

Chronic Spontaneous Urticaria

Keywords

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

Outcome Measures

Primary Outcomes (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)

  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.

  Last 7 days of second dosing period, 44 weeks

Secondary Outcomes (7)

• 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)

  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)

  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)

  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

  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

  7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period

Study Arms (2)

omalizumab 150mg

EXPERIMENTAL

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

omalizumab 300mg

EXPERIMENTAL

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

omalizumab DRUG

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

omalizumab 150mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (35)

Novartis Investigative Site

Pilar, Buenos Aires, 1629, Argentina

Location

Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000CXH, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1125ABE, Argentina

Location

Novartis Investigative Site

Salta, A4400ERH, Argentina

Location

Novartis Investigative Site

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Novartis Investigative Site

Alphaville / Barueri, São Paulo, 06454-010, Brazil

Location

Novartis Investigative Site

Santo André, São Paulo, 09060-650, Brazil

Location

Novartis Investigative Site

Edmonton, Alberta, T5K 1X3, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V6H 3K2, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Novartis Investigative Site

Halifax, Nova Scotia, B3J 3R4, Canada

Location

Novartis Investigative Site

Barrie, Ontario, L4M 6L2, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8S 1G5, Canada

Location

Novartis Investigative Site

Kingston, Ontario, K7L 2V7, Canada

Location

Novartis Investigative Site

Markham, Ontario, L3P 1A8, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1Y 4G2, Canada

Location

Novartis Investigative Site

Peterborough, Ontario, K9J 5K2, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M4V 1R2, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 1E2, Canada

Location

Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

Location

Novartis Investigative Site

Windsor, Ontario, N8X 2G1, Canada

Location

Novartis Investigative Site

Québec, Quebec, GIV 4M6, Canada

Location

Novartis Investigative Site

Toronto, M4C 5M5, Canada

Location

Novartis Investigative Site

Santiago, 8207257, Chile

Location

Novartis Investigative Site

Santiago, 8420383, Chile

Location

Novartis Investigative Site

Santo Domingo, Republica Dominicana, Dominican Republic

Location

Novartis Investigative Site

Guatemala City, 01015, Guatemala

Location

Novartis Investigative Site

Zapopan, Jalisco, 45190, Mexico

Location

Novartis Investigative Site

Tlalpan, Mexico City, 14050, Mexico

Location

Novartis Investigative Site

Panama City, Panama

Location

Related Publications (1)

• 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.

  PMID: 32272284 DERIVED

MeSH Terms

Conditions

Chronic Urticaria; Urticaria; Angioedema; Pruritus

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 11, 2014
• Study Start: August 1, 2014
• Primary Completion: November 3, 2016
• Study Completion: November 3, 2016
• Last Updated: September 13, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-08

Locations

AR (5); BR (4); CA (19); ME (2); GU (1); CL (2); PA (1); DO (1)