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  1. Medical Information Right
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  3. Taltz (ixekizumab) injection Right
  4. What were the inclusion and exclusion criteria in Taltz® (ixekizumab) plaque psoriasis clinical trials?
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Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

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.

US_cFAQ_IXE002_INCLUSION_EXCLUSION_PsO
US_cFAQ_IXE002_INCLUSION_EXCLUSION_PsOen-US

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

  • with an sPGA (0,1) with at least a 2-point improvement from baseline, and
  • achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75).1,2

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 and Exclusion Criteria in Phase 3 UNCOVER Clinical Trials1,2

Key Inclusion Criteria

Patients were eligible to be included in the trials only if they met all of the following criteria:

Key Exclusion Criteria

Patients were excluded from the trials if they had any of the following criteria:

  • Male or female patients aged 18 years or older
  • Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
  • At least 10% BSA of psoriasis at screening and baseline
  • sPGA score ≥3 and PASI score ≥12 at screening and baseline
  • Candidate for phototherapy and/or systemic therapy
  • If male, must agree to use a reliable method of birth control or remain abstinent during the study
  • If female, must agree to use reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
  • Pustular, erythrodermic, and/or guttate forms of psoriasis
  • History of drug-induced psoriasis
  • Prior use of etanercept
  • Clinically significant flare of psoriasis during the 12 weeks prior to baseline
  • Concurrent or recent (<5 half-lives prior to baseline) use of any biologic agent
  • Received nonbiologic systemic psoriasis therapy or phototherapy (including PUVA and UVB) within 4 weeks prior to baseline or had topical psoriasis treatment within the previous 2 weeks prior to baseline
  • Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study
  • Participated in any study with IL-17 antagonists, including ixekizumab
  • Serious disorder or illness other than plaque psoriasis that would pose an unacceptable risk to the patient or interfere with the interpretation of data
  • Serious infection within the last 12 weeks prior to baseline
  • Evidence or suspicion of active or latent TB
  • Breastfeeding or nursing (lactating) women

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

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

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

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