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Taltz ® (ixekizumab) injection
80 mg/mL
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What were the inclusion and exclusion criteria in Taltz® (ixekizumab) plaque psoriasis clinical trials?
Key inclusion and exclusion criteria for the phase 3 ixekizumab trials in patients with active plaque psoriasis are included in this response.
Inclusion and Exclusion Criteria in Plaque Psoriasis Clinical Trials
UNCOVER-1, UNCOVER-2, and UNCOVER-3 trials were multicenter, randomized, double-blind, placebo-controlled phase 3 trials that enrolled a total of 3866 patients aged 18 years or older with moderate-to-severe plaque psoriasis who were candidates for phototherapy and/or systemic therapy with
- body surface area ≥10% involvement
- static Physician Global Assessment (sPGA) ≥3 on a severity scale of 0 to 5, and
- Psoriasis Area and Severity Index (PASI) ≥12 on a severity scale of 0 to 72.1
All 3 pivotal trials used the same efficacy outcome measures and coprimary endpoints at week 12. The coprimary endpoints were the proportion of patients
To ensure consistency in the target patient population and disease severity, identical inclusion and exclusion criteria were used across the pivotal trials. Exclusion criteria regarding prior and concomitant therapy as well as medical history and safety screening were identical across the pivotal trials (except allowance for prior etanercept use in UNCOVER-1).1,2
Key Inclusion and Exclusion Criteria in Phase 3 UNCOVER Clinical Trials summarizes key inclusion and exclusion criteria for the 3 pivotal UNCOVER trials.
The complete list of inclusion and exclusion criteria is available in the supplementary material of Gordon et al.1
Key Inclusion Criteria |
Key Exclusion Criteria |
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Abbreviations: BSA = body surface area; IL-17 = interleukin 17; PASI = Psoriasis Area and Severity Index; PUVA = psoralens and ultraviolet A; sPGA = static Physician Global Assessment; TB = tuberculosis; UVB = ultraviolet B.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
2Griffiths CEM, Reich K, Lebwohl M, et al; UNCOVER-2, UNCOVER-3 Investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015;386(9993):541-551. https://doi.org/10.1016/S0140-6736(15)60125-8
Date of Last Review: October 25, 2024