This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Key facts

Study ID

NCT03926611

Run by

Novartis Pharmaceuticals

People needed

311

Starts

2019-06-06

Expected to finish

2021-04-15

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged ≥18 years of age
• CSU diagnosis for ≥ 6 months prior to screening
• Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period
• UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1)
• Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study

You may not qualify if…

• Hypersensitivity to any of the study treatments
• Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
• Other diseases with symptoms of urticaria or angioedema
• Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results,
• Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential not using highly effective methods of contraception

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Mission Viejo, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Westminster, California, United States
• Novartis Investigative Site — Pembroke Pines, Florida, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Ypsilanti, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Grove City, Ohio, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — La Plata, Buenos Aires, Argentina
• Novartis Investigative Site — Mendoza, Mendoza Province, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Edegem, Antwerpen, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Niagara Falls, Ontario, Canada
• Novartis Investigative Site — Ottawa, Ontario, Canada
• Novartis Investigative Site — Verdun, Quebec, Canada
• Novartis Investigative Site — Québec, Canada
• Novartis Investigative Site — Prague, Czech Republic, Czechia
• Novartis Investigative Site — Prague, Prague 1, Czechia
• Novartis Investigative Site — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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