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NCT07811869

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

ClinicalTrials.gov identifier NCT07811869

Novartis reference CLOU064R12302

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 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
NCT07811869

Study of an Investigational Treatment for Severe Chronic Itching With No Known Cause

ClinicalTrials.gov identifier NCT07811869

Novartis reference CLOU064R12302

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 who have severe, long-lasting itching with no known cause. This condition is called chronic pruritus of unknown origin. It means a person has ongoing itching, but the study doctor cannot find a clear medical reason for it.

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, participants will receive the investigational treatment for another 28 weeks. People who received placebo in the first part will switch to the investigational treatment at that time. After treatment ends, there will be a 4-week period with no study treatment so the study team can continue to check safety.

This study may be an option for
Adults with chronic pruritus 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 origin (not mainly caused by a skin disease, a body-wide condition, nerve-related or mental health causes, medicines, or other allergen exposures)
Have itching in at least 2 of these areas: trunk, arms, or legs (and it is not only on 1 side of the body and not in a band-like pattern)
Still have severe itching even though they have used moisturizers (emollients), and are a candidate for body-wide (systemic) treatment
Have severe itch based on itch rating scores at screening and again before starting treatment, including a daily itch score tracked over the 7 days before the baseline visit

Study timeline and visits:
Participation lasts up to 60 weeks total. This includes up to 4 weeks of screening, 24 weeks of the first treatment period, 28 weeks of the second treatment period, and 4 weeks of 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 origin at the baseline visit (for example, the itching is not related to a main skin disease or body-wide condition, is not nerve-related or mental health–related, and is not caused by medicines or other allergen exposures)
Have chronic itching that affects at least 2 of these body areas: trunk, arms, or legs (the itching cannot be only on 1 side of the body and cannot follow a single nerve pattern)
Have ongoing, severe chronic itching even though they have used moisturizers (emollients), and are a candidate for body-wide (systemic) treatment
Have severe itch at screening based on a Worst Itch Numeric Rating Scale (WI-NRS) score of 7 or higher (on a 0 to 10 scale, where higher numbers mean worse itch)
Have an average WI-NRS score of 7 or higher over the 7 days before the baseline/randomization visit
Have daily WI-NRS scores (0 to 10) recorded for the 7 days before the baseline/randomization visit, so the 7-day average can be calculated
Have a Patient Global Impression of Severity (PGIS) itch score of 3 (“severe”) at the screening visit and at the baseline visit

You might not be able to join if

Have any active skin condition (such as atopic dermatitis or psoriasis) that could make it hard to assess chronic pruritus of unknown origin
Have a known body-wide condition or take a medication that the study doctor thinks is 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 thinks would prevent participation (this includes, but is not limited to, infections such as tuberculosis, atypical mycobacterial infections, listeriosis, aspergillosis, and known or suspected HIV infection)
Have had cancer in any organ system within the past 5 years, whether treated or not, except for localized basal cell skin cancer or cervical cancer in situ
Have a significant risk of bleeding or a blood-clotting disorder
Have a history of clinically important gastrointestinal bleeding (for example, bleeding related to nonsteroidal anti-inflammatory drugs [NSAIDs]) where medical intervention was needed or where hospitalization or a blood transfusion was required
Need anti-platelet medication, except aspirin up to 100 mg per day or clopidogrel up to 75 mg per day
Use dual anti-platelet therapy (for example, aspirin plus clopidogrel)
Have a history of liver disease or currently have liver disease, including (but not limited to) acute or chronic hepatitis, cirrhosis, or liver failure
Have screening lab results showing AST or ALT more than 1.5 times the upper limit of normal, or an INR more than 1.5

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