Oral Tablet

Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score from baseline.

Defined as time taken for the participant to achieve a ≥4 improvement in Itch NRS score from baseline.

Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".

Itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".

Defined as percentage of participants that achieve a ≥ 4-point improvement in Itch NRS score from baseline.

Defined as percentage of participants that achieve an IGA-CPG-S score of 0 or 1 with a ≥ 2 grade improvement from baseline.

Defined as percentage of participants that achieve an IGA-CPG-A score of 0 or 1 with a ≥ 2 grade improvement (reduction) from baseline.

The modified PAS will be used in this study as defined by the protocol.

Defined as percentage of participants that achieve a ≥ 4-point improvement (reduction) in Itch NRS score and IGA-CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline.

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days.

The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days.

Defined as percentage of participants with at least a 4-point decrease in DLQI score from baseline at each postbaseline visit for participants with DLQI score ≥ 4 at baseline.

Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".

Skin Pain NRS is an 11-point scale (0 to10) where 0 is "no pain" and 10 is the "worst pain imaginable".

HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).

HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).

The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome.

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days.

Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.