Phase 2
Completed N=311
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Source: ClinicalTrials.gov NCT03926611 ↗Enrolled (actual)
311
Serious AEs
1.7%
Results posted
Feb 2022
Primary outcomePrimary: Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 — -19.10; -19.08; -14.65; -15.99 Scores on a scale — p=<0.0001
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 |
-19.10; -19.08; -14.65; -15.99; -20.02; -18.06 | <0.0001 sig |
| SECONDARY Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 |
-18.11; -17.97; -15.27; -17.67; -20.21; -17.38 | <0.0001 sig |
| SECONDARY Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6) |
29.5; 29.5; 29.8; 31.8; 41.9; 26.7 | — |
| SECONDARY Cumulative Number of Weeks With an AAS7=0 Response |
10.2; 10.5; 10.0; 9.8; 10.3; 9.2 | — |
| SECONDARY Percentage of Participants With DLQI Score of 0 or 1 |
38.6; 29.5; 29.8; 29.5; 51.2; 33.3 | — |
| SECONDARY Mean Change From Baseline in DLQI Score |
-9.60; -8.38; -7.18; -6.20; -9.21; -6.15 | — |
| SECONDARY Area Under the Blood Concentration-time Curve (AUC) of LOU064 |
45.2; 131; 427; 55.9; 107; 418 | — |
| SECONDARY Observed Maximum Blood Concentration (Cmax) of LOU064 |
27.6; 67.2; 194; 32.2; 55.5; 196 | — |
| SECONDARY Time to Reach the Maximum Concentration (Tmax) of LOU064 |
1.33; 1.54; 1.52; 0.900; 1.15; 1.52 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03926611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.