Trial · NCT03971643
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | From treatment start until end of study (including observational visits), an average of 249 days | Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here. |
| Secondary | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | From treatment start until V16 (Day 189) | Efficacy endpoint: Proportion of patients with a clinical response, defined as Physician's Global Assessment (PGA) score ≤3 of target ulcer at Visit V4, V6, V10 and V16 (End of Treatment \[EOT\]) (SAF). PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse |
| Secondary | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | From treatment start until end of study (including observational visits), an average of 249 days | Efficacy endpoint: Kaplan-Meier analysis of time to first clinical remission (complete closure of target ulcer) defined as PGA score of ≤ 1, PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse |
| Secondary | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change in wound area \[percent change\] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. |
| Secondary | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change in wound volume \[percent change\] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. |
| Secondary | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Rate of change per day in area of target ulcer \[mm²/day\] between Visits V1 and V16 (photographic assessment) |
| Secondary | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of ≥ 50% by photographic assessment at Visit V16 (EOT) compared to Baseline |
| Secondary | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to Baseline (remission) (photographic assessment) |
| Secondary | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment) |
| Secondary | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment) |
| Secondary | Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change from Baseline in pain assessed by Numeric Rating Scale (NRS) \[percent change\] at visits V4, V6, V10 and V16 (EOT) Mean (SD) The NRS is an 11-point scale (from 0 represent no pain to 10 representing the worst pain the subject can imagine). |
| Secondary | Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change from Baseline in Dermatology Life Quality Index (DLQI) \[percent change\] at visits V4, V6, V10, and V16 (EOT) The DLQI comprises 10 questions with single scores 0 (No effect on patient's life) to 3 (large effect on patient's life). The DLQI total score is calculated by summing up the score of each question resulting in a minimum of 0 (best) and a maximum of 30 (worst). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03971643/registered