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NCT07700056

A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

ClinicalTrials.gov identifier NCT07700056

Novartis reference CLOU064R12301

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Condition Chronic Pruritus of Unknown Origin

Study status Recruiting

Phase 3

Number of participants 180

Gender All

Age 18 years or above

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Study details

This is a global, phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of remibrutinib in adult participants with severe CPUO.

The design includes 4 periods, for a total duration of up to 60 weeks:

Screening period: up to 4 weeks.
Double-blind treatment period (treatment period 1, TP1): 24 weeks of double-blind treatment with remibrutinib or matching placebo
Open-label treatment period (treatment period 2, TP2): 28 weeks of open-label treatment with remibrutinib. The participants randomized to the placebo arm will be switched to remibrutinib at Week 24.
Safety follow-up period: 4 weeks of treatment-free safety follow-up.

Interventions

DRUG: Remibrutinib|DRUG: Placebo

Official title

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

Inclusion Criteria

Participant must be ≥ 18 years of age, at the time of signing the informed consent.
Participants with chronic pruritus for at least 4 months prior to screening.
Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures).
Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution).
Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy.
Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch.
Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit.
The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10).
Participants must have PGIS of pruritus scored as 3 "severe" at screening and baseline visits.

Exclusion Criteria

Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO.
Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus.
Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected HIV infection.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.

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Clinical trials
NCT07700056

Study of an Investigational Treatment for Severe Chronic Itching of Unknown Cause

ClinicalTrials.gov identifier NCT07700056

Novartis reference CLOU064R12301

Show study information as

Condition Chronic Pruritus of Unknown Origin

Study status Recruiting

Phase 3

Number of participants 180

Gender All

Age 18 years or above

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in adults with severe chronic itching of unknown origin. This condition means a person has long-lasting itching, but the doctor cannot find a clear cause such as a skin disease, another medical condition, nerve-related itching, mental health-related itching, medicines, or allergen exposures.

Participants will receive either the investigational treatment or a placebo for 24 weeks. A placebo looks like the investigational treatment but does not contain active medication. After that, all participants will receive the investigational treatment for 28 weeks. People who received placebo will switch to the investigational treatment at that time. After treatment ends, participants will have a 4-week period with no study treatment for safety follow-up.

This study may be an option for
Adults with severe chronic itching of unknown origin may be able to participate if they:

Are 18 years of age or older
Have had chronic itching for at least 4 months
Have itching that the study doctor considers to be of unknown cause
Have itching that affects at least 2 of these body areas: trunk, arms, or legs
Still have severe itching even though they have used moisturizers (emollients), and are candidates for whole-body (systemic) treatment
Have severe itching based on study rating scales at screening and again before starting treatment, including daily itch ratings for 7 days

Study timeline and visits:
Participation lasts up to 60 weeks. This includes up to 4 weeks of screening, 24 weeks of blinded treatment (investigational treatment or placebo), 28 weeks where everyone receives the investigational treatment, and 4 weeks of safety follow-up without study treatment.

Interventions

DRUG: Remibrutinib|DRUG: Placebo

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Are 18 years of age or older at the time they sign the consent form
Have had chronic itching for at least 4 months before screening
Have chronic itching that the study doctor considers to be of unknown cause at the start of the study (for example, not caused by a main skin disease or another body-wide condition, not nerve-related or mental health-related, and not caused by medicines or other allergen exposures)
Have chronic itching that affects at least 2 of these areas: trunk, arms, or legs (the itching cannot be on only 1 side of the body and cannot follow a single nerve/stripe-like pattern)
Have ongoing, severe chronic itching despite using moisturizers (emollients) and are a candidate for whole-body (systemic) treatment
Have severe itching at screening based on an itch rating scale score of 7 or higher (on a 0 to 10 scale where higher numbers mean worse itching)
Have an average itch rating scale score of 7 or higher during the 7 days before the randomization/baseline visit
Have daily itch rating scale scores (0 to 10) that are used to calculate the 7-day average before the randomization/baseline visit
Have a “severe” itching score on a patient global severity scale at both the screening visit and the baseline visit

You might not be able to join if

Have any active skin condition (such as atopic dermatitis or psoriasis) that could interfere with assessing itching of unknown origin
Have a known body-wide condition or take a medication that the study doctor considers to be the main cause of the current itching
Have a known or suspected infection that is active, long-lasting, or keeps coming back, and that the study doctor believes would prevent participation (this includes, but is not limited to, opportunistic infections such as tuberculosis, atypical mycobacterial infections, listeriosis, or aspergillosis, and/or known or suspected HIV infection)
Have had cancer in any organ system within the past 5 years (this does not include localized basal cell skin cancer or cervical cancer in situ), whether treated or untreated, even if there is no sign it has come back or spread
Have a significant risk of bleeding or a blood-clotting disorder, including a history of clinically important gastrointestinal bleeding (for example, bleeding linked to NSAID use that needed medical treatment, hospitalization, or a blood transfusion)
Need anti-platelet medicine, except for aspirin up to 100 mg per day or clopidogrel up to 75 mg per day
Use 2 anti-platelet medicines at the same time (for example, aspirin plus clopidogrel)
Have a past or current liver disease (including, but not limited to, acute or chronic hepatitis, cirrhosis, or liver failure), or have screening lab results showing liver enzymes (AST/ALT) more than 1.5 times the upper limit of normal or an INR more than 1.5

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