REMIBRUTINIB for Chronic inducible urticaria | Chronic spontaneous urticaria

Inclusion criteria

• {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study.\n- Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.\n- CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization The following response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1): • Symptomatic dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0. • Cold urticaria: A Critical Threshold Temperature of ≥15°C using the TempTest® 4.0. • Cholinergic urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test after the provocation test. • Heat urticaria: Documented emergence of urticaria symptoms following heat exposure • Solar urticaria: Documented emergence of urticaria symptoms following sunlight exposure and UVA/B or light exposure/phototesting record from source records • Delayed pressure urticaria: symptoms of urticaria as diagnosed by pressure provocation with dermographometer or local application of weight on the lesional skin area (symptoms should be observed 4h to 6h after the trigger) and can be documented by the participant when outpatient. • Aquagenic urticaria: Evidence of urticaria (in patient records) after local exposure to water (e.g. wet blanket or other suitable testing approach). • Contact urticaria: Evidence of urticaria following contact to identified material causing urticaria symptoms.\n- CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more\n- CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022a) not adequately controlled with H1‑AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following: • UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization • CSU for ≥ 6 months\n- Participants must be willing and able to attend the protocol defined test procedure throughout the study"}

Exclusion criteria

• {"criterion_text":"- Participants who have a familial/hereditary form (e.g. familial cold autoinflammatory syndrome, familial cold urticaria) of the target CINDU that is being considered for the participant's inclusion in this study\n- Diseases, other than CSU or CINDU, with urticaria or angioedema symptoms including but not limited to: •\turticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), •\tfood allergies yielding urticaria symptoms when the allergen is not avoided by the dietary habits of the participant •\thereditary or acquired angioedema.\n- CINDU patients only: To prevent a confounding effect of CSU symptoms, the CINDU study population will consist of participants with predominant CINDU and shoud not have a signficant share of CSU symptoms (that might make the assessment of CINDU symptoms difficult) as per the investigator's judgement.\n- CSU patients only: Patients should have no relevant inducible urticaria trigger\n- Any other skin disease associated with chronic itching that might influence, in the investigator’s opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism.\n- Known or suspected ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known positivity for Human Immunodeficiency Virus (HIV) infection\n- Pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization"}

Primary endpoints

• {"endpoint_text":"- Absolute change from baseline in the weekly most bothersome symptom Numeric Rating Scale (NRS) score on the Urticaria Symptom Daily Diary (USDD) at Week 6","definition_or_measurement_approach":"Measured as absolute change from baseline in the weekly most bothersome symptom NRS score collected via the Urticaria Symptom Daily Diary (USDD) at Week 6."}
• {"endpoint_text":"- Absolute change from baseline in Urticaria Control Test 7 (UCT7) weekly scores at Week 6","definition_or_measurement_approach":"Measured as absolute change from baseline in weekly UCT7 scores at Week 6."}

Secondary endpoints

• {"endpoint_text":"- Absolute change from baseline in Urticaria Control test 7 (UCT7) weekly scores at Week 2 and Week 12","definition_or_measurement_approach":"Measured as absolute change from baseline in weekly UCT7 scores at Week 2 and Week 12."}
• {"endpoint_text":"- Dermatology Life Quality Index (DLQI) response defined as DLQI= 0-1 at Week 2, Week 6 and Week 12","definition_or_measurement_approach":"Proportion of participants achieving DLQI score 0-1 at Weeks 2, 6 and 12."}
• {"endpoint_text":"- Absolute change from baseline in USDD weekly component scores at Week 2, Week 6 and Week 12; this includes the change in itch, pain and burning NRS from baseline.","definition_or_measurement_approach":"Measured as absolute change from baseline in USDD weekly component scores (itch, pain, burning NRS) at Weeks 2, 6 and 12."}
• {"endpoint_text":"- Safety endpoints will include but not be limited to: • Occurrence of treatment emergent adverse events (AEs) • Occurrence of treatment emergent serious adverse events (SAEs) • Occurrence of treatment emergent adverse events of special interest (AESIs)","definition_or_measurement_approach":"Safety assessed by recording occurrence and frequency of treatment-emergent AEs, SAEs and AESIs during treatment and follow-up per standard safety reporting procedures."}

France

Earliest CTIS Part Ii Submission Date

21-04-2025

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

28

Number Of Sites

4

Number Of Participants

7

Germany

Earliest CTIS Part Ii Submission Date

13-03-2025

Latest Decision Or Authorization Date

21-05-2025

Processing Time Days

69

Number Of Sites

4

Number Of Participants

14

Spain

Earliest CTIS Part Ii Submission Date

16-04-2025

Latest Decision Or Authorization Date

26-05-2025

Processing Time Days

40

Number Of Sites

4

Number Of Participants

12

Poland

Earliest CTIS Part Ii Submission Date

17-04-2025

Latest Decision Or Authorization Date

25-05-2025

Processing Time Days

38

Number Of Sites

3

Number Of Participants

6

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

code: 12

Name

IQVIA Limited

Responsibilities

codes: 1,14,3

Name

Syneos Health Inc.

Responsibilities

code: 1

Name

Icon Clinical Research Limited

Responsibilities

code: 1

Name

Medidata Solutions Inc.

Responsibilities

codes: 6,7

Third parties

• {"country":"France","full_name":"Aliri France","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"EPL Archives GmbH","duties_or_roles":"Long- term biomarker sample storage","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Medical Supplies and Equipments","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"SGS France","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long- term biomarker sample storage","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient and site training guide and tools","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Patient Reported Outcomes (PRO), Electronic Patient Reported Outcomes ((e)PRO)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 1,14,3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 6,7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products returned from sites to local depot","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Kayentis","duties_or_roles":"Patient Reported Outcomes (PRO), Electronic Patient Reported Outcomes ((e)PRO); code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Local purchase of medicinal products (AxMP)","organisation_type":"Pharmaceutical company"}