Across 52 unique European CTIS-authorized Phase II & III psoriasis / psoriatic arthritis trials, PASI response or score was the most frequently measured endpoint family, appearing in 31 trials (59.6%). Safety endpoints appeared in 24 trials (46.2%), ACR response in 23 (44.2%), and sPGA/PGA/IGA global assessment in 21 (40.4%). Primary endpoints split by disease: ACR response led in psoriatic arthritis, while PASI and global assessment led in plaque psoriasis.
PASI response or score appeared in 31/52 trials (59.6%), followed by safety endpoints in 24/52 (46.2%), ACR response in 23/52 (44.2%), and sPGA/PGA/IGA global assessment in 21/52 (40.4%).
The endpoint landscape is dual-centred: skin-response measurement is anchored by PASI in 31 trials, while joint-response measurement is anchored by ACR in 23 trials. Safety endpoints remain a broad cross-cutting layer in 24 trials, especially in long-term extension, paediatric, and later-stage protocols.
Primary endpoints concentrated around ACR response (19/52, 36.5%), PASI response/score (12/52, 23.1%) and global assessment (10/52, 19.2%). Secondary endpoints were broader, with PASI in 23/52 trials (44.2%) and safety in 19/52 (36.5%).
| ACR response | 19/52 | 36.5% |
| PASI response/score | 12/52 | 23.1% |
| sPGA/PGA/IGA global assessment | 10/52 | 19.2% |
| Safety / AEs / labs / vitals | 6/52 | 11.5% |
| PK / exposure | 5/52 | 9.6% |
| PsA disease activity composites | 3/52 | 5.8% |
| PASI response/score | 23/52 | 44.2% |
| Safety / AEs / labs / vitals | 19/52 | 36.5% |
| PsA disease activity composites | 18/52 | 34.6% |
| ACR response | 17/52 | 32.7% |
| BSA / skin surface | 17/52 | 32.7% |
| Treatment persistence / loss of response | 16/52 | 30.8% |
Primary endpoint selection is narrower than secondary endpoint selection. ACR, PASI and global assessment together define the main efficacy hierarchy, while secondary endpoints add durability, BSA, quality-of-life/function PROs and safety to support regulatory and clinical interpretation.
Psoriatic arthritis accounted for 23/52 trials (44.2%), plaque psoriasis for 17/52 (32.7%), and mixed PsO/PsA or adjacent inflammatory arthritis for 12/52 (23.1%). In plaque psoriasis, PASI appeared in 13/17 trials (76.5%); in psoriatic arthritis, ACR appeared in 20/23 (87.0%).
| Sub-disease label | Trials | Share |
|---|---|---|
| Adult / active psoriatic arthritis | 19/52 | 36.5% |
| Moderate-to-severe plaque psoriasis | 9/52 | 17.3% |
| Plaque psoriasis, other specified | 8/52 | 15.4% |
| Mixed / adjacent inflammatory disease | 7/52 | 13.5% |
| Juvenile psoriatic arthritis / JPsA | 6/52 | 11.5% |
| Chronic plaque psoriasis | 3/52 | 5.8% |
Plaque psoriasis trials are visibly skin-score driven: PASI and global assessments dominate. Psoriatic arthritis trials are joint-response driven: ACR appeared in 20/23 trials and PsA disease-activity composites in 13/23. Mixed inflammatory trials are less endpoint-standardized and more safety/durability oriented, with safety in 8/12.
Phase III trials represented 39/52 trials (75.0%), Phase II represented 12/52 (23.1%), and one Phase II/III bridge trial represented 1/52 (1.9%). Phase III used PASI in 24/39 trials (61.5%), while Phase II used safety in 8/12 (66.7%).
Phase III trials show the most conventional confirmatory pattern: PASI, ACR, global assessment, BSA and safety all appear in at least 16/39 trials. Phase II trials are more heterogeneous, with safety in 8/12 and PK/exposure in 0/12, reflecting dose-finding, early efficacy, imaging and extension-study objectives.
Biologic / antibody-led trials were the largest modality group (31/52, 59.6%), followed by small-molecule trials (14/52, 26.9%). In biologic / antibody-led trials, PASI appeared in 18/31 (58.1%); in small-molecule trials, PASI appeared in 10/14 (71.4%).
Biologic / antibody-led trials are balanced across skin and joint endpoints, with PASI in 18/31 and ACR in 16/31. Small-molecule trials skew more strongly toward skin-score packages, with PASI in 10/14, BSA in 9/14 and global assessment in 8/14.
For the 52-trial European CTIS cohort, the median interval from initial CTIS submission to first CTIS authorization was 111.0 days, with a mean of 96.7 days and a range of 29–130 days. Phase III trials had a median of 115.0 days, compared with 107.5 days for Phase II.
| Phase | Trials | Median days | Range |
|---|---|---|---|
| Phase III | 39/52 | 115.0 | 29–130 |
| Phase II | 12/52 | 107.5 | 48–122 |
| Phase II/III bridge | 1/52 | 36.0 | 36–36 |
The CTIS timeline is commercially relevant for European endpoint planning: protocols with PASI, ACR, paediatric PK, safety extension, or mixed-disease endpoint packages still clustered around a 111.0-day median authorization interval. The 2026 cohort’s median of 115.0 days indicates that recent psoriasis/PsA EU submissions should be planned with roughly three to four months between initial CTIS submission and first authorization.
| PASI | Psoriasis Area and Severity Index; commonly reported as PASI 75, PASI 90 or PASI 100 response. |
| sPGA / PGA / IGA | Static Physician Global Assessment, Physician Global Assessment, or Investigator Global Assessment of skin disease severity. |
| ACR | American College of Rheumatology response criteria, typically ACR20, ACR50 or ACR70 in psoriatic arthritis trials. |
| PRO / QoL | Patient-reported outcome and quality-of-life measures, including DLQI, CDLQI, HAQ-DI, PsAQoL, SF-36, PSSD and itch/pain NRS. |
| CTIS | Clinical Trials Information System, the EU portal used for clinical trial submission and authorization under the EU Clinical Trials Regulation. |