# 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

> **NCT05677451** · PHASE3 · RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 100 (estimated)

## Conditions studied

- Chronic Spontaneous Urticaria

## Interventions

- **DRUG:** LOU064 (blinded)
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT05677451
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-07-11
- **Primary completion:** 2026-11-06
- **Final completion:** 2032-03-30
- **Target enrollment:** 100 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05677451

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05677451, "24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT05677451. Licensed CC0.

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