Phase 2
Completed N=60
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT01483924 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Feb 2015
Primary outcomePrimary: Number of Patients With Adverse Events — 4; 5; 7; 6 participants
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events |
4; 5; 7; 6; 5 | — |
| SECONDARY Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 |
18.3; 53.0; 138.5; 164.9 | — |
| SECONDARY Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 |
4.00; 3.00; 3.00; 4.00 | — |
| SECONDARY AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14 |
134.7; 368.4; 973.7; 1294.0 | — |
| SECONDARY T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14 |
2.8; 2.6; 2.8; 2.8 | — |
| SECONDARY Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores |
-3.8; -3.8; -2.0; -3.4; -2.8 | 0.9048 |
| SECONDARY Efficacy of APO805K1 as Assessed by Achievement of PASI-75 |
16.7; 16.7; 0.0; 0.0; 8.3 | 0.1975 |
| SECONDARY Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores |
-0.8; -1.2; -0.6; -0.5; -0.7 | 0.6349 |
| SECONDARY Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score |
-1.0; -0.8; -0.5; -0.9; -1.3 | 0.6212 |
Eligibility Criteria
Main Inclusion Criteria:
- A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥10.
- Male and female subjects 18 to 65 years of age, inclusive.
- At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
- Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.
Main Exclusion Criteria:
- Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
- Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
- Phototherapy within 30 days prior to Baseline assessment and during the study.
- Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
- History of liver disease or abnormal liver enzymes
- Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
- Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
- Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
- History of chronic infection or malignancy
Data sourced from ClinicalTrials.gov (NCT01483924). 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.