Study: NCT05956314

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Clinical global impression of severity (CGI-S)
Description: Lesions severity will be assessed using the CGI-S scale, which is a 5-point scale (from 0= none to 4= very severe) modified from Busner et al. 2007 (30) by the investigator during screening and on Days 1 (baseline, prior to first dosing), 7, 28, 42, 63, 84, 112, 140, and at ET visit - where applicable, per cohort).~The clinician scoring takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms (pain), behaviour, and the impact of the symptoms on the patient's ability to function (ability to walk). investigators will complete the CGI-S at various timepoints based on the question. Please choose the response that best describes your assessment of the disease severity, based upon the totality of information available to you

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Clinical global impression of severity (CGI-S)
Description: Lesions severity will be assessed using the CGI-S scale, which is a 5-point scale (from 0= none to 4= very severe) modified from Busner et al. 2007 (30) by the investigator during screening and on Days 1 (baseline, prior to first dosing), 7, 28, 42, 63, 84, 112, 140, and at ET visit - where applicable, per cohort).~The clinician scoring takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms (pain), behaviour, and the impact of the symptoms on the patient's ability to function (ability to walk). investigators will complete the CGI-S at various timepoints based on the question. Please choose the response that best describes your assessment of the disease severity, based upon the totality of information available to you

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Visual Analogue Scale (VAS) pain scale
Description: The patient will enter the PPPK- or PC-related pain score (not any pain) using a VAS pain scale in the patient-reported diary, on a weekly basis starting on Day 1 through ET visit, prior to the second administration of the IMP (evening dose) at the same time every time (±1 hour) except for Day 1 (Visit 2, in-clinic visit), where the assessment will be performed pre-dose during the visit.~The score will be collected on every in-clinic visit during the treatment and follow up periods (Days 1, 7, 28, 42, 63, 84, 112, 140, and at an ET visit - where applicable, per cohort).~The following parameter will be evaluated on a VAS from 0 (no pain) to 100 (severe intolerable pain) based on the question:~How was your worst pain intensity in the past 24 hours?

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Visual Analogue Scale (VAS) pain scale
Description: The patient will enter the PPPK- or PC-related pain score (not any pain) using a VAS pain scale in the patient-reported diary, on a weekly basis starting on Day 1 through ET visit, prior to the second administration of the IMP (evening dose) at the same time every time (±1 hour) except for Day 1 (Visit 2, in-clinic visit), where the assessment will be performed pre-dose during the visit.~The score will be collected on every in-clinic visit during the treatment and follow up periods (Days 1, 7, 28, 42, 63, 84, 112, 140, and at an ET visit - where applicable, per cohort).~The following parameter will be evaluated on a VAS from 0 (no pain) to 100 (severe intolerable pain) based on the question:~How was your worst pain intensity in the past 24 hours?

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Peak pruritus-numerical rating scale (PP-NRS)
Description: The peak pruritus severity will be assessed using the PP-NRS, an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The PP-NRS will be entered by the patients on a weekly basis starting on Day 1 through ET visit, preferably after the evening dose, at the same time every time (±1 hour) except for Day 1 (Visit 2, in-clinic visit), where the assessment will be performed pre-dose during the visit.~The scores will be collected on every in-clinic visit during the treatment and follow up periods (Days 1, 7, 28, 42, 63, 84, 112, and 140, or at an ET visit - where applicable, per cohort).~The PP-NRS was designed to measure peak pruritus, or worst itch, over the previous 24 hours based on the following question: On scale from 0 (no itch) to 10 (worst imaginable itch) how was your worst itch in the past 24 hours?

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Peak pruritus-numerical rating scale (PP-NRS)
Description: The peak pruritus severity will be assessed using the PP-NRS, an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). The PP-NRS will be entered by the patients on a weekly basis starting on Day 1 through ET visit, preferably after the evening dose, at the same time every time (±1 hour) except for Day 1 (Visit 2, in-clinic visit), where the assessment will be performed pre-dose during the visit.~The scores will be collected on every in-clinic visit during the treatment and follow up periods (Days 1, 7, 28, 42, 63, 84, 112, and 140, or at an ET visit - where applicable, per cohort).~The PP-NRS was designed to measure peak pruritus, or worst itch, over the previous 24 hours based on the following question: On scale from 0 (no itch) to 10 (worst imaginable itch) how was your worst itch in the past 24 hours?

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Patient global impression of change (PGI-C) scoring
Description: The PGI will be evaluated on Days 1, 7, 28, 42, 63, 84, 112, and 140, or at an ET visit - where applicable, per cohort.~The PGI-C will be evaluated using a 7-point scale from 1 (very much improved) to 7 (very much worse) as follows:~Since the start of the trial, my overall status has:~from, 1= very much improved to 7= very much worse

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Patient global impression of change (PGI-C) scoring
Description: The PGI will be evaluated on Days 1, 7, 28, 42, 63, 84, 112, and 140, or at an ET visit - where applicable, per cohort.~The PGI-C will be evaluated using a 7-point scale from 1 (very much improved) to 7 (very much worse) as follows:~Since the start of the trial, my overall status has:~from, 1= very much improved to 7= very much worse