Phase 1
Completed N=76
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
Source: ClinicalTrials.gov NCT00563524 ↗Enrolled (actual)
76
Serious AEs
2.6%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) — 3; 9; 7; 11 Participants
Summary
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) |
3; 9; 7; 11; 9; 9 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters |
3; 3; 2; 3; 4; 3 | — |
| PRIMARY Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) |
2; 0; 3; 2; 5; 4 | — |
| PRIMARY Number of Participants With Laboratory Test Values of Potential Clinical Importance |
10; 10; 7; 10; 7; 7 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose |
6.292; 20.151; 79.475; 167.916 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose |
7.096; 19.222; 63.133; 113.523 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose |
152.50; 107.77; 4.00; 3.00 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose |
48.07; 119.94; 2.00; 3.00 | — |
| SECONDARY Terminal-phase Disposition Rate Constant of ILV-094: Single Dose |
NA; NA; 0.06623; 0.08079 | — |
| SECONDARY Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose |
NA; NA; 0.04554; 0.05302 | — |
| SECONDARY Terminal Half-Life (t1/2) of ILV-094: Single Dose |
NA; NA; 10.64; 8.69 | — |
| SECONDARY Terminal Half-Life (t1/2) of ILV-094: Multiple Dose |
NA; NA; 15.43; 13.45 | — |
| SECONDARY Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose |
1333; 4212; 8880; 21358 | — |
| SECONDARY Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose |
1532; 4241; 9474; 18352 | — |
| SECONDARY Apparent Clearance of ILV-094: Multiple Dose |
30.944; 22.536; 15.092; 15.586 | — |
| SECONDARY Apparent Volume of Distribution of ILV-094: Multiple Dose |
NA; NA; 7953; 7174 | — |
| SECONDARY Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose |
4.809; 13.206; 29.580; 57.287 | — |
| SECONDARY Accumulation Ratio (Rac) of ILV-094 |
2.739; 2.147; 2.134; 1.684 | — |
| SECONDARY Serum C-Reactive Protein (CRP) Levels |
0.700; 1.943; 0.939; 0.446; 0.625; 1.142 | 0.5237 |
| SECONDARY Serum Interleukin-6 (IL-6) Levels |
3.14; 13.05; 4.93; 2.66; 2.46; 8.99 | 0.3833 |
| SECONDARY Serum Amyloid-A Levels |
26586201; 33048188; 22784245; 13112923; 32684269; 34103493 | 0.7051 |
| SECONDARY Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 |
13.1; 13.5; 2.57; 14.0; 20.1; 11.3 | — |
| SECONDARY Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 |
1.38; 0.75; 1.00; 1.00; 1.69; 1.38 | — |
| SECONDARY Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 |
0.46; 0.33; 0.17; 0.55; 0.54; 0.23 | — |
Eligibility Criteria
Inclusion Criteria
- Men and Women of nonchildbearing potential 18 years or older.
- Physician Area and Severity Index (PASI) greater than 11.
- Physician Global Assessment (PGA) greater than 3.
Exclusion Criteria
- Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
- Live vaccines within 3 months before test article administration or during the study.
- Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
- Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
- Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
- Receipt of systemic psoriasis therapy (eg, oral retinoids, methotrexate, hydroxyurea, cyclosporine, or azathioprine) or systemic corticosteroids within 4 weeks before study day 1.
- Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength [class 6 or 7 topical corticosteroids], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)
Data sourced from ClinicalTrials.gov (NCT00563524). 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.