Phase 2
Completed N=20
High Dose Risankizumab for Psoriasis
Source: ClinicalTrials.gov NCT05283135 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Oct 2025
Primary outcomePrimary: CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52 — 9.60; 26.71; 1.60; 16.63 number of cells
Summary
This pilot study explores higher than standard doses of risankizumab for plaque psoriasis, to see effects on resident memory T cells and skin clearance.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD8+ Trm1 Cells in Lesional Skin at Baseline and Week 52 |
9.60; 26.71; 1.60; 16.63 | — |
| PRIMARY CD8+ Trm17 Cells in Lesional Skin at Baseline and Week 52 |
19.67; 22.88; 3.20; 5.00 | — |
| SECONDARY PASI 100 Results in Patients Receiving 4X Standard Induction Doses of Risankizumab vs. Those Receiving 2X Standard Induction Doses of Risankizumab. |
7; 8; 6; 6; 4; 4 | — |
| SECONDARY Safety Events |
11; 11; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has provided written consent
- Subject has the ability to comply with all study visits and procedures
- Subject is at least 18 years of age
- Subject has chronic stable plaque psoriasis for at least 6 months and with a severity of BSA greater than or equal to 10 and PASI greater than or equal to 12
- Female subjects of child-bearing potential must have a negative urine test at screening and baseline. Female subjects must be either postmenopausal, or permanently surgically sterile, or for women of child-bearing potential practicing at least one form of birth control
Exclusion Criteria
- Breastfeeding or pregnant women, or women who plan to become pregnant during study period
- Participation in any other clinical trial
- Active infection with HIV, hepatitis B virus, or hepatitis C virus
- Active infection with tuberculosis or untreated latent tuberculosis
- History of known active cancer, other than non-melanoma skin cancer or cervical carcinoma in situ, in the past 3 years
- History of drug or alcohol abuse in the past 6 months, as per investigator's assessment
- History of suicidal ideation or attempts in the past 6 months
- Presence of any concurrent illness, which in the opinion of the investigator, would place the patient at unnecessary safety risk during the trial or interfere with completion of the trial
- Treatment with topical medications for psoriasis in the past 2 weeks
- Treatment with oral medications for psoriasis in the past 4 weeks
- Phototherapy for psoriasis in the past 4 weeks
- Any prior treatment with Risankizumab
- Treatment with biologic medications for psoriasis (other than Risankizumab) in the past 4 months
Data sourced from ClinicalTrials.gov (NCT05283135). 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.