A Phase 4 Mechanistic Longitudinal Study to Evaluate the Impact of EARLY Risankizumab Treatment on TRM Cell Levels in Moderate-to-Severe Psoriasis

Conditions

Psoriasis

Brief summary

The change in the number of epidermal and dermal CD8+CD103+ TRM cells at week 16 (compared to baseline lesional levels) in moderate to severe psoriasis patients treated with per label doses of risankizumab in early versus late treatment.

Detailed description

1. The percentage of patients with PASI 0 (complete clearance) at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment. The percentage of patients with PASI ≤ 1 at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment., 2. The change in the number of epidermal and dermal CD8+CD103+ TRM cells at week 16 (compared to baseline non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment. The reduction in the number of epidermal and dermal CD8+CD103+ TRM cells at week 52 (compared to baseline lesional and non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment., 3. Reduction of systemic inflammatory and CV associated biomarkers vs baseline levels at weeks 16 and 52 in early versus late treatment., 4. Safety events from week 0 to week 60 in patients receiving at least one dose of risankizumab.

Related papers

No related papers found yet.

Interventions

DRUGSkyrizi 150 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in the number of epidermal and dermal CD8+CD103+ TRM cells at week 16 (compared to baseline lesional levels) in moderate to severe psoriasis patients treated with per label doses of risankizumab in early versus late treatment.	—

Secondary

Measure	Time frame
1. The percentage of patients with PASI 0 (complete clearance) at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment. The percentage of patients with PASI ≤ 1 at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment., 2. The change in the number of epidermal and dermal CD8+CD103+ TRM cells at week 16 (compared to baseline non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment. The reduction in the number of epidermal and dermal CD8+CD103+ TRM cells at week 52 (compared to baseline lesional and non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment., 3. Reduction of systemic inflammatory and CV associated biomarkers vs baseline levels at weeks 16 and 52 in early versus late treatment., 4. Safety events from week 0 to week 60 in patients	—

Measure

Time frame

1. The percentage of patients with PASI 0 (complete clearance) at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment. The percentage of patients with PASI ≤ 1 at weeks 4, 16, 28, 40, and 52 in patients treated with per label doses of risankizumab in early versus late treatment., 2. The change in the number of epidermal and dermal CD8+CD103+ TRM cells at week 16 (compared to baseline non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment. The reduction in the number of epidermal and dermal CD8+CD103+ TRM cells at week 52 (compared to baseline lesional and non-lesional levels) in psoriasis patients treated with per label doses of risankizumab in early versus late treatment., 3. Reduction of systemic inflammatory and CV associated biomarkers vs baseline levels at weeks 16 and 52 in early versus late treatment., 4. Safety events from week 0 to week 60 in patients

—

Countries

Spain

Outcome results

None listed