Phase 3
Completed N=235
Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.
Source: ClinicalTrials.gov NCT01961609 ↗Enrolled (actual)
235
Serious AEs
12.9%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks — 65.3 Percentage of participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study was designed to prove and quantify the hypothesis that secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to anti-TNFα therapy in a United Kingdom (UK) and Republic of Ireland) specific population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks |
65.3 | <0.0001 sig |
| SECONDARY Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks |
44.3 | — |
| SECONDARY Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks |
71.4; 70.5; 47.7; 38.9; 61.9; 32.4 | — |
| SECONDARY Percentage of Participants Achieiving PASI 75 - Initiation Period |
1.7; 2.6; 27.1; 18.3; 60.2; 40.0 | — |
| SECONDARY Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period |
72.0; 75.8; 2.7; 61.7; 68.2; 13.5 | — |
| SECONDARY Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period |
65.1; 80.6; 18.8; 4.2; 65.1; 58.1 | — |
| SECONDARY Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period |
28.0; 25.2; 63.6; 57.4; 84.7; 67.8 | — |
| SECONDARY Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period |
89.7; 95.5; 24.3; 80.4; 89.4; 54.1 | — |
| SECONDARY Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period |
88.0; 96.8; 75.0; 50.0; 74.7; 80.6 | — |
| SECONDARY Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks |
70.7; 55.0 | — |
| SECONDARY Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks |
81.4; 60.9 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period |
-15.6; -13.2; -16.1; -12.3 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period |
-16.3; -15.9; -6.1; -15.7; -14.4; -8.7 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period |
-17.2; -14.7; -11.5; -7.7; -17.0; -13.0 | — |
| SECONDARY Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period |
76.25; 72.92; 76.30; 75.25 | — |
| SECONDARY Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period |
77.33; 80.48; 67.03; 79.16; 80.05; 69.14 | — |
| SECONDARY Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period |
80.22; 83.87; 74.50; 67.63; 78.24; 80.88 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed
- Aged at least 18 years at screening
- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
- Moderate to severe disease severity:
- PASI ≥10 and
- DLQI >10
- Failed to respond to systemic therapies including cyclosporine and/or methotrexate and/or PUVA (or is intolerant and/or has a contraindication to these)
- Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Key Exclusion Criteria
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids (CS), UV therapy). Washout periods detailed in the protocol must be adhered to.
- Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before initiation of study drug.
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
- Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
- Active systemic infections during the last two weeks (exception: common cold) prior to initiation of study drug and any infections that reoccur on a regular basis; investigator discretion should be used regarding patients who have travelled or recently resided in areas of endemic mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis and for patients with underlying conditions that may predispose them to infection, such as advanced or poorly controlled diabetes
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to UK guidelines.
- Known infection with HIV, hepatitis B or hepatitis C at screening or at initiation of study drug.
Data sourced from ClinicalTrials.gov (NCT01961609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.