Phase 4
Completed N=15
Immunologic Response to Secukinumab in Plaque Psoriasis
Source: ClinicalTrials.gov NCT02592018 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Aug 2020
Primary outcomePrimary: Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline — -1.42 percent change from week 0
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 is a single-arm, open-label study, which will examine the effect of secukinumab on the immunologic and genetic environment within psoriatic lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of CD4+ T Effector Cells Expressing IL17 Compared to Baseline |
-0.17 | — |
| SECONDARY Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline Across All Participants |
67 | — |
| SECONDARY Change in Number of Differentially Expressed Genes in CD4+ Effectors Compared to Baseline |
1618 | — |
| SECONDARY Change in Number of Differentially Expressed Genes in CD4+ T Regs Compared to Baseline |
127 | — |
| SECONDARY Change in Number of Differentially Expressed Genes in CD8+ T Effectors Compared to Baseline |
104 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
- Subject is considered a candidate for phototherapy or systemic therapy
- PASI ≥ 12
- PGA ≥ 3
- Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR negative, subject initiated prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
- Physical exam within clinically acceptable limits.
Exclusion Criteria
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age.
- Subject has predominately non-plaque form of psoriasis.
- Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
- Subject has drug-induced psoriasis.
- Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
- Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
- Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
- Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis defined by positive QFT with a negative chest X-ray without prophylactic therapy with isoniazid for a course of 9 months with one month of therapy completed prior to first dose of secukinumab.
- History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
- Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's psoriasis.
- History of known or suspected intolerance to any of the ingredients of the investigational study product.
Data sourced from ClinicalTrials.gov (NCT02592018). 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.