Phase 3
Completed N=966
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01406938 ↗
Enrolled (actual)
966
Serious AEs
3.9%
Results posted
May 2015
Primary outcomePrimary: For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 — 62.1; 78.2; 52.4; 67.7 Percent of participants
Summary
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 |
62.1; 78.2; 52.4; 67.7 | — |
| SECONDARY Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 |
-7.46; -9.28; -11.13; -12.97; -14.18; -15.90 | — |
| SECONDARY Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52 |
-21.52; -22.32; -23.19; -21.58; -21.23; -22.61 | — |
| SECONDARY Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction) |
1.2; 3.1; 1.9; 5.2; 20.2; 32.9 | — |
| SECONDARY Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period)) |
70.9; 82.4; 74.8; 83.4; 90.1; 92.1 | — |
| SECONDARY Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction) |
5.9; 7.6; 10.8; 13.6; 17.5; 18.3 | — |
| SECONDARY Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance) |
21.4; 23; 23.4; 23.9; 20.6; 23 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction) |
-5.5; -6; -8.2; -8.7; -10.2; -10.3 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance) |
-11; -11.4; -11.4; -11.3; -10.6; -11 | — |
| SECONDARY % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction) |
9.5; 13.8; 23.2; 33.2; 44.7; 52.1 | — |
| SECONDARY % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance). |
59.8; 66.5; 58.4; 72.1; 57.4; 67.6 | — |
| SECONDARY Median Time to Relapse (Weeks) From Week 12. |
NA; NA; NA; 302 | — |
| SECONDARY Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy |
42.9; 66.7; 4.3; 14.3; 81; 86.1 | — |
| SECONDARY Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1 |
1.5; 0.9; 0.5; 0.5; 1; 0.5 | — |
| SECONDARY Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12 |
4.1; 0.8; 40.2; 0; 27.8; 45.3 | — |
| SECONDARY Number of Participants Developing Anti-secukinumab Antibodies |
2; 1; 1; 1 | — |
Eligibility Criteria
Inclusion criteria
- Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
Severity of disease meeting all of the following three criteria:
- PASI score of 12 or greater,
- Investigator's Global Assessment (IGA) score of 3 or greater
- Total body surface area (BSA) affected of 10% or greater.
- Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria
- Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
- Current drug-induced psoriasis.
- Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
- Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
- Hematological abnormalities.
- History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
- History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01406938). 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.