Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05007756 | A Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest | EARLY_PHASE1 | COMPLETED | 24 | — | — | Jul 14, 2021 | Nov 4, 2021 | Dec 10, 2021 | 1 | Belgium |
Changes in gene expression as measured by counts of transcript per million reads in control versus challenged tissue will be reported.
Changes in gene set variation analysis (GSVA) enrichment score control versus challenged tissue will be reported. The GSVA score is a measurement of changes in a set of genes between 2 sample sets (example, control versus test).
Changes in cell count as measured by fluorescence intensity via immunohistochemistry (IHC) in control versus challenged tissue will be reported.
Changes in protein expression as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported.
Changes in gene expression as measured by fluorescence intensity via IHC in control versus challenged tissue will be reported.
Changes in the levels of proteins and phosphoproteins which are relevant to inflammatory pathways thought to be activated by ultraviolet B (UVB) exposure (example, Type 1 interferons pathways) measured by enzyme-linked immunoassay (ELISA) in control versus challenged tissue lysates, will be reported.
Fold changes in the mean differences of the levels of the proteins and phosphoproteins which are relevant to inflammatory pathways thought to be activated by UVB exposure (example, type 1 interferons pathways) measured by ELISA in control versus challenged tissue lysates, will be reported.
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state.
Number of participants with TEAEs by MedDRA SOC with a frequency threshold of at least 2 participants per intervention cohort will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| Ultraviolet B (UVB) Challenge | EXPERIMENTAL | Participants will receive UVB (various doses) for minimal erythema dose (MED) assessment at baseline following which there will be washout period. Participants will then receive a single dose of UVB challenge dermally through Lumera Phototherapy System on Day 1, twice (2\*) the MED at the challenge site with no UVB exposure at the contralateral control site. |
| Name | Type | Description |
|---|---|---|
| UVB Challenge | RADIATION | UVB challenge will be administered dermally through Lumera Phototherapy System. |
Inclusion Criteria: * A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-HCG\]) at screening and a negative urine pregnancy test prior to study intervention administration on Day -4 * Must have Fitzpatrick skin type II or III (10 ...