Table 2.
Key clinical trial endpoints
| Trial name | Investigated therapy | Phase | Primary endpoint | Key secondary endpoint(s) | NCT number |
|---|---|---|---|---|---|
| XTEND-CIU [39, 62] | Omalizumab | IV | Percentage of participants with CIU/CSU clinical worsening by UAS7 ≥ 12 for at least 2 consecutive weeks from W24–W48 |
Time to CIU/CSU clinical worsening by UAS7 ≥ 12 for at least 2 consecutive weeks Percentage of participants with CIU/CSU clinical worsening by UAS7 > 6 for at least 2 consecutive weeks Change from W24–W48 in UAS7 |
NCT02392624 |
| OPTIMA [38, 63] | Omalizumab | III | Number of participants with UAS7 ≤ 6 after the initial dosing period, relapsed (UAS7 ≥ 16) when treatment was discontinued and who achieved UAS7 ≤ 6 at W44 |
The difference in UAS7 between the start and end of the second dosing period Number of participants with UAS7 ≤ 6 after the second dosing period Time to relapse (UAS7 ≥ 16) after drug withdrawal in participants who responded to the initial dosing period |
NCT02161562 |
| X-ACT [64, 65] | Omalizumab | III | Change from baseline to W36 in the CU-Q2oL |
Number of angioedema-burdened days from baseline to W36 Change from baseline to W36 in the AAS7 Change from baseline to W36 in the AE-Q2oL Change from baseline to W36 in the DLQI |
NCT01723072 |
| ASTERIA I [34] | Omalizumab | III | Change from baseline to W12 in the ISS7 |
Change from baseline to W12 in the UAS7 Change from baseline to W12 in the weekly number of hives score Time to MCID response (≥ 5-point decrease) in ISS7 by W12 Percentage of participants with UAS7 ≤ 6 at W12 |
NCT01287117 |
| ASTERIA II [35] | Omalizumab | III | Change from baseline to W12 in the ISS7 |
Change from baseline to W12 in the UAS7 Change from baseline to W12 in the weekly number of hives Time to achieve MCID (≥ 5-point decrease) in the ISS7 The proportion of participants with UAS7 ≤ 6 |
NCT01292473 |
| GLACIAL [37] | Omalizumab | III | Safety |
Change from baseline to W12 in the ISS7 Change from baseline to W12 in the UAS7 Change from baseline to W12 in the weekly number of hives Time to achieve MCID (≥ 5-point decrease) in ISS7 The proportion of participants with UAS7 ≤ 6 |
NCT01264939 |
| N/A [66] | Ligelizumab | IIb | The proportion of participants with HSS7 = 0 at W12 |
The proportion of participants with HSS7 = 0 at W12 and W20 Change from baseline in HSS7, ISS7, UAS7 and AAS7 |
NCT02477332 |
| N/A [27, 67] | Benralizumab | IV | Change from baseline to W20 in the UAS7 | Safety and tolerability | NCT03183024 |
| N/A [28] | Fenebrutinib | II | Change from baseline to W8 in the UAS7 |
The proportion of participants with UAS7 ≤ 6 at W8 Change from baseline to W4 in the UAS7 |
|
| N/A [31] | Remibrutinib | IIb | Change from baseline to W4 in UAS7 |
Change from baseline to W12 in UAS7 The proportion of participants with UAS7 = 0 The proportion of participants with UAS7 ≤ 6 Safety and tolerability |
NCT03926611 |
| REMIX-1 [33] | Remibrutinib | III |
Change from baseline to W12 in UAS7 Absolute change in ISS7 at W12 Absolute change in HSS7 at W12 |
The proportion of participants with UAS7 ≤ 6 at W12 The proportion of participants with UAS7 = 0 at W12 The proportion of participants with UAS7 ≤ 6 at W2 The proportion of participants with DLQI = 0–1 at W12 The proportion of participants with AAS = 0 at W12 |
NCT05030311 |
| REMIX-2 [32] | Remibrutinib | III |
Change from baseline to W12 in UAS7 Absolute change in ISS7 at W12 Absolute change in HSS7 at W12 |
The proportion of participants with UAS7 ≤ 6 at W12 The proportion of participants with UAS7 = 0 at W12 The proportion of participants with UAS7 ≤ 6 at W2 The proportion of participants with DLQI = 0–1 at W12 The proportion of participants with AAS = 0 at W12 |
NCT05032157 |
| N/A [29] | Bilastine/levocetirizine | III | Change from baseline to W6 in the UAS7 |
Change from baseline to W6 in the DLQI Change from baseline to W6 in the VAS |
N/A |
| MUCIS [68, 69] | Methotrexate | III | Number of participants with complete urticaria remission at W18 |
Safety and tolerability Number of participants with pruritus at W18 and W26 Number of participants with complete remission at W26 |
NCT01960283 |
| N/A [30] | Levocetirizine | IV | Change from baseline to W4 in the UAS and TSS |
Change from baseline to W4 in the patient’s global assessment of disease activity Change from baseline to W4 in the physician’s global assessment of disease activity |
N/A |
| N/A [36] | Bilastine | II/III | Change from baseline to W2 in the TSS |
Change from baseline to days 1–3 in the TSS Change from baseline to W1 in the TSS |
N/A |
AAS7 weekly Angioedema Activity Score, AE-QoL Angioedema Quality of Life Questionnaire, CIU chronic idiopathic urticaria, CSU chronic spontaneous urticaria, CU-Q2oL Chronic Urticaria Quality of Life questionnaire, DLQI Dermatology Life Quality Index, HSS7 weekly Hive Severity Score, ISS7 weekly Itch Severity Score, MCID minimal clinically important difference, N/A not applicable, TSS urticaria Total Severity Score, UAS Urticaria Activity Score, UAS7 weekly Urticaria Activity Score, VAS Visual Analog Scale, W week