Across 217 unique European CTIS dermatology Phase II & III trials authorized in 2024–2026, endpoint measurement is dominated by safety, clinician global assessment, and patient-reported outcomes. Safety or treatment-emergent adverse event endpoints appear in 142/217 trials (65.4%), investigator global assessment endpoints in 106/217 (48.8%), and quality-of-life or patient-reported outcome endpoints in 96/217 (44.2%). Secondary endpoints carry most of the endpoint payload, accounting for 1,785/2,140 endpoint entries (83.4%).
Safety / treatment-emergent adverse event (TEAE) endpoints are the most frequent endpoint family, appearing in 142/217 trials (65.4%). Investigator Global Assessment (IGA) endpoints appear in 106/217 trials (48.8%), while quality-of-life or patient-reported outcome (PRO) endpoints appear in 96/217 trials (44.2%).
For EU/CTIS dermatology submissions, endpoint planning is not limited to one disease-specific severity scale. A competitive endpoint package usually needs a safety backbone, a clinician-rated activity or clearance scale, and a PRO/QoL layer.
Primary endpoint entries account for 348/2,140 endpoint entries (16.3%), secondary endpoints account for 1,785/2,140 (83.4%), and exploratory/other endpoints account for 7/2,140 (0.3%). At the trial level, 206/217 trials (94.9%) list primary endpoints, 180/217 (82.9%) list secondary endpoints, and only 3/217 (1.4%) list exploratory/other endpoints.
| Top primary families | Primary frequency | Top secondary families | Secondary frequency |
|---|---|---|---|
| Safety / TEAEs | 46/217 · 21.2% | Safety / TEAEs | 116/217 · 53.5% |
| Investigator global assessment | 41/217 · 18.9% | Quality of life / PRO | 95/217 · 43.8% |
| EASI / eczema severity | 23/217 · 10.6% | Investigator global assessment | 92/217 · 42.4% |
| Biomarker / laboratory | 22/217 · 10.1% | Biomarker / laboratory | 68/217 · 31.3% |
| Survival / event-time | 19/217 · 8.8% | Survival / event-time | 58/217 · 26.7% |
| Hidradenitis response | 18/217 · 8.3% | Pain score | 46/217 · 21.2% |
| Oncology response / RECIST | 16/217 · 7.4% | Body surface / lesion extent | 46/217 · 21.2% |
| PASI / psoriasis severity | 13/217 · 6.0% | Pruritus / itch score | 38/217 · 17.5% |
The primary endpoint layer is built around safety, global assessment, EASI, biomarker/lab measures, survival/time-to-event, and disease-specific response scales. The secondary layer is broader and more patient-centered: safety appears in 116/217 trials (53.5%), QoL/PRO in 95/217 (43.8%), and IGA in 92/217 (42.4%).
The largest disease groups are atopic dermatitis/eczema with 34/217 trials (15.7%), dermatologic oncology with 25/217 (11.5%), psoriasis/psoriatic disease with 23/217 (10.6%), and hidradenitis suppurativa with 22/217 (10.1%). Within these groups, the dominant endpoint families are disease-specific: EASI/IGA in atopic dermatitis, PASI/IGA in psoriasis, HiSCR/IHS4 in hidradenitis suppurativa, and RECIST/objective response in dermatologic oncology.
| Disease group | Trials | Most frequent family | Second family | Third family |
|---|---|---|---|---|
| Atopic dermatitis / eczema | 34 | IGA: 30/34 · 88.2% | EASI: 26/34 · 76.5% | Safety: 25/34 · 73.5% |
| Dermatologic oncology | 25 | Oncology response / RECIST: 15/25 · 60.0% | Safety: 15/25 · 60.0% | Survival/event-time: 12/25 · 48.0% |
| Psoriasis / psoriatic disease | 23 | PASI: 20/23 · 87.0% | IGA: 16/23 · 69.6% | BSA / lesion extent: 12/23 · 52.2% |
| Hidradenitis suppurativa | 22 | HiSCR / IHS4: 19/22 · 86.4% | Safety: 18/22 · 81.8% | Pain: 13/22 · 59.1% |
| Urticaria / angioedema | 12 | UAS / HSS: 12/12 · 100.0% | Safety: 9/12 · 75.0% | Pruritus: 8/12 · 66.7% |
| Systemic sclerosis | 12 | mRSS / SSc endpoints: 10/12 · 83.3% | QoL / PRO: 9/12 · 75.0% | Safety: 8/12 · 66.7% |
| Rare / severe skin disease | 12 | Biomarker / laboratory: 9/12 · 75.0% | Safety: 9/12 · 75.0% | QoL / PRO: 6/12 · 50.0% |
| Wounds / burns / ulcers | 11 | Wound closure / detachment: 8/11 · 72.7% | Safety: 6/11 · 54.5% | Biomarker/lab: 5/11 · 45.5% |
| Sub-disease | Trials | Dominant endpoint signal |
|---|---|---|
| Atopic dermatitis | 29 | Primary EASI in 21/29 · 72.4% |
| Hidradenitis suppurativa | 22 | Primary HiSCR/IHS4 in 18/22 · 81.8% |
| Plaque psoriasis | 13 | Primary PASI in 10/13 · 76.9% |
| Chronic spontaneous urticaria | 11 | Primary UAS/HSS in 9/11 · 81.8% |
| Melanoma | 10 | Any oncology response in 6/10 · 60.0% |
| Psoriatic arthritis | 10 | Primary ACR/JIA response in 7/10 · 70.0% |
| Alopecia / hair disorders | 9 | Primary hair/SALT endpoint in 7/9 · 77.8% |
| Systemic sclerosis | 9 | Primary mRSS/SSc endpoint in 5/9 · 55.6% |
| Vitiligo | 8 | Primary VASI endpoint in 7/8 · 87.5% |
| Skin infection / infestation | 8 | Primary infection success in 7/8 · 87.5% |
| Basal cell carcinoma / Gorlin | 6 | Primary oncology response in 4/6 · 66.7% |
Disease-specific severity scales are the clearest endpoint anchors in CTIS dermatology submissions. Atopic dermatitis relies on EASI/IGA, plaque psoriasis on PASI/IGA, hidradenitis on HiSCR/IHS4, urticaria on UAS/HSS, vitiligo on VASI, and systemic sclerosis on mRSS/SSc measures.
Phase II-containing records include 109 CTIS phase records and Phase III-containing records include 114; six explicit Phase II/III trials contribute to both phase buckets. Phase III carries 1,262 endpoint entries across 114 records, or 11.1 per record, compared with 926 endpoint entries across 109 Phase II records, or 8.5 per record.
| Endpoint measure | Phase II-containing | Phase III-containing |
|---|---|---|
| Any-role safety / TEAEs | 82/109 · 75.2% | 64/114 · 56.1% |
| Any-role IGA / global assessment | 47/109 · 43.1% | 62/114 · 54.4% |
| Any-role QoL / PRO | 44/109 · 40.4% | 56/114 · 49.1% |
| Any-role biomarkers / laboratory | 54/109 · 49.5% | 32/114 · 28.1% |
| Any-role PK / exposure | 29/109 · 26.6% | 12/114 · 10.5% |
| Endpoint entries per record | 926/109 · mean 8.5 | 1,262/114 · mean 11.1 |
| Secondary endpoint entries | 748/109 · mean 6.9 | 1,078/114 · mean 9.5 |
Phase II endpoint design is more translational: biomarkers/lab measures appear in 54/109 records (49.5%) and PK/exposure in 29/109 (26.6%). Phase III shifts toward confirmatory clinical and patient-centered measurement, with IGA in 62/114 records (54.4%) and QoL/PRO in 56/114 (49.1%).
Small molecules appear in 107/217 trials (49.3%), monoclonal antibodies in 69/217 (31.8%), peptide/protein/enzyme products in 36/217 (16.6%), and other modalities in 21/217 (9.7%). Safety endpoints remain the most consistent modality-agnostic endpoint family, ranging from 21/36 peptide/protein/enzyme trials (58.3%) to 15/21 other-modality trials (71.4%).
| Modality group | Trials | Most frequent | Second | Third |
|---|---|---|---|---|
| Small molecule | 107 | Safety 70/107 · 65.4% | IGA 56/107 · 52.3% | QoL/PRO 47/107 · 43.9% |
| Monoclonal antibody | 69 | Safety 43/69 · 62.3% | QoL/PRO 39/69 · 56.5% | IGA 32/69 · 46.4% |
| Peptide/protein/enzyme | 36 | Safety 21/36 · 58.3% | IGA 19/36 · 52.8% | PK/exposure 11/36 · 30.6% |
| Other | 21 | Safety 15/21 · 71.4% | QoL/PRO 10/21 · 47.6% | Biomarker/lab 10/21 · 47.6% |
For CTIS endpoint planning, modality mainly changes the supporting endpoint layer. Peptide/protein/enzyme trials show a larger PK/exposure footprint at 11/36 (30.6%), while monoclonal antibody trials show more QoL/PRO use at 39/69 (56.5%).
A combined patient-reported or symptom endpoint layer—QoL/PRO, pruritus/itch, or pain—appears in 123/217 trials (56.7%). This layer is most common in urticaria/angioedema at 10/12 trials (83.3%), rare/severe skin disease at 9/12 (75.0%), systemic sclerosis at 9/12 (75.0%), hidradenitis suppurativa at 16/22 (72.7%), and atopic dermatitis/eczema at 23/34 (67.6%).
The strongest adjacent operational signal is eCOA/PRO readiness. More than half of the EU dermatology CTIS trial set includes patient-reported, itch, or pain endpoints, making validated instruments and multilingual patient-facing workflows central to Phase II & III execution.
CTIS means the European Clinical Trials Information System. TEAE means treatment-emergent adverse event. IGA means Investigator Global Assessment. EASI means Eczema Area and Severity Index. PASI means Psoriasis Area and Severity Index. HiSCR means Hidradenitis Suppurativa Clinical Response. UAS7 means weekly Urticaria Activity Score. VASI means Vitiligo Area Scoring Index. mRSS means modified Rodnan Skin Score. PRO means patient-reported outcome. PK means pharmacokinetics.