Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

NCT05170724 | Unknown

• 1 other identifier: CLOU064A2002M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide access to remibrutinib for adult patients with chronic spontaneous urticaria (CSU)

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic Spontaneous Urticaria; CSU; MAP; Managed Access Program; Remibrutinib; Early Access; Expanded Access; LOU064; Urticaria; Skin Disease; Cohort MAP

Interventions

Remibrutinib DRUG

Remibrutinib should be taken in accordance with the recommendations in the treatment plan.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female subjects (≥ 18 years) who are able and willing to provide written informed consent prior to enrolling in the cohort.
• CSU diagnosis for ≥ 6 months (defined as onset of CSU with supporting documentation).
• Diagnosis of CSU refractory to H1-AH at locally label approved doses and to omalizumab (where applicable), as assessed by the treating physician, using one of the following tools: UAS7, UCT or DLQI
• Not eligible or able to enroll in a clinical trial or no relevant clinical trials available

You may not qualify if:

• Patients eligible for this Treatment Plan must not meet any of the following criteria:
• Previous premature discontinuation from a remibrutinib clinical trial for any reason
• History of hypersensitivity to remibrutinib or its excipients or to other BTK inhibitors
• Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria
• Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
• Any other skin disease associated with chronic itching that might influence in the physician's opinion the treatment effect, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
• Use of prohibited concomitant treatment
• Known history or evidence of ongoing alcohol or drug abuse within the last 6 months before treatment start
• 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
• Pregnant or nursing (lactating) women
• Women of child-bearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping of program treatment. Highly effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
• Male sterilization (at least 6 months prior to screening). For female participants in the program, the vasectomized male partner should be the sole partner for that participant
• Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Chronic Urticaria; Urticaria; Skin Diseases

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 28, 2021
• Last Updated: December 5, 2025

Record last verified: 2025-12