Trial · NCT03902184
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From the first dose until study completion, an expected average of 2 years | Using the Olsen (2011, JCO) criteria (All cohorts) |
| Secondary | Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts) | From first dose until study completion, an expected average of 2 years | patients with treatment-related adverse events as assessed by CTCAE v5.0 |
| Secondary | Quality of life (QoL) (All cohorts) | Through study completion, an expected average of 2 years | Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning |
| Secondary | pruritus (All cohorts) | Through study completion, an expected average of 2 years | Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be |
| Secondary | ORR using blinded central review (Cohort 1) | From the first dose until study completion, an expected average of 2 years | Using the Olsen (2011, JCO) criteria |
| Secondary | Progression free survival (PFS) (All cohorts) | From the first dose until study completion, an expected average of 2 years | Will be evaluated using the Kaplan-Meier method |
| Secondary | Overall survival (OS) (All cohorts) | From the first dose until study completion, an expected average of 2 years | Will be evaluated using the Kaplan-Meier method |
| Secondary | PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts) | From the first dose until study completion, an expected average of 2 years | Maximum Plasma Concentration (Cmax) (W1, W5) |
| Secondary | PK parameters :Trough Concentration of IPH4102 alone (All cohorts) | From the first dose until study completion, an expected average of 2 years | Trough Concentration (Ctrough) every 8 or 12 weeks |
| Secondary | Immunogenicity of IPH4102 alone (All cohorts) | From the first dose until study completion, an expected average of 2 years | A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA). |
| Secondary | Duration of Response (DOR) | From the first dose until study completion, an expected average of 2 years | Will be summarized descriptively by using the Kaplan-Meier estimator |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03902184/registered