Remibrutinib for Chronic Urticaria

(RECLAIM Trial)

Recruiting at 21 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Second generation antihistamines

Must not be taking: Anticoagulants, Dual anti-platelet

Disqualifiers: Cardiovascular, Neurological, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 17

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Are You a Good Fit for This Trial?

Adults with moderate to severe chronic spontaneous urticaria (CSU) not well-controlled by second generation H1-antihistamines can join. They must have had CSU for at least 6 months, score high enough on specific severity scales, and be able to keep a daily diary of their condition. Participants should also have recent medical documentation of hives.

Inclusion Criteria

I have had hives within the last 3 months or it's in my medical history.

I can keep a daily diary for my urticaria as required.

My UAS7 score is 16 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Core Treatment

Participants receive either remibrutinib or dupilumab as an add-on treatment to second generation H1-antihistamines for 12 weeks

12 weeks

Weekly visits (in-person)

Optional Open-label Extension

Participants may opt into continuation of remibrutinib treatment for an additional 12 weeks if it is not commercially available

12 weeks

Safety Follow-up

Participants are monitored for safety after treatment completion

12 weeks

Phone calls at Week 16 and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Remibrutinib

Trial Overview The trial is testing the effectiveness of Remibrutinib versus Dupilumab in improving symptoms at early stages (within 4 weeks). Both drugs are added to standard antihistamine treatments. Patients will randomly receive either drug or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Treatment group 1: Remibrutinib + Placebo Experimental Treatment 2 Interventions

Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week \[Weeks 2-10\])

Group II: Treatment group 2: Dupilumab + remibrutinib matching placebo Active Control 2 Interventions

Dupilumab pre-filled syringe (600 mg loading dose \[2 x 300 mg dupilumab s.c. injection\] at baseline visit followed by dupilumab 300 mg s.c. injection every other week \[Weeks 2-10\]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD