GX29107

F. Hoffmann-La Roche AG

Grenzacherstrasse 124, Basel, Switzerland, CH-4070

Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com

Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com

No

No

No

Final

07 Jan 2015

No

Yes

23 Oct 2014

No

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of quilizumab administered subcutaneously (SC) as add-on therapy for the treatment of adult participants (18 − 75 years old) who had been diagnosed with chronic spontaneous urticaria (CSU) and who remained symptomatic despite treatment with H1 antihistamines (including doses up to four times above the approved dose level) with or without leukotriene receptor antagonist (LTRA).

This study was conducted in accordance with the United States (US) Food and Drug Administration (FDA) regulations, the International Conference on Harmonization E6 Guideline for Good Clinical Practice, and applicable local, state, and federal laws, as well as other applicable country laws. Approval from the Institutional Review Board (IRB)/Ethics Committee (EC) was obtained before study start and was documented in a letter to the investigator specifying the date on which the committee met and granted the approval. Sponsor also obtained approval from the relevant regulatory authority prior to starting the study.

05 Dec 2013

No

No

Canada: 15

Germany: 17

32

17

0

0

0

0

0

0

30

2

0

Overall Study (overall period)

Randomised - controlled

Yes

Placebo

Solution for injection

Subcutaneous use

Participants received three 1.5 milliliter (mL) SC injections at each of the two dosing visits.

Quilizumab

Solution for injection

Subcutaneous use

Participants received three 1.5 mL SC injections at each of the two dosing visits.

Placebo

Quilizumab

Placebo

Quilizumab

The itch severity score was recorded once daily in the participant’s diary, on a scale of 0 (none) to 3 (intense). The baseline weekly itch score was the sum of the daily itch scores over the 7 days prior to randomization (Day 1 visit). The weekly itch score was the sum of the daily scores over the last 7 days prior to the time point of interest. Total weekly itch severity score ranged from 0 to 21, where higher scores indicated more intense itching. Analysis was performed on modified intention-to-treat (mITT) population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using worst observation carried forward (WOCF).

Primary

Baseline, Week 20

The LS mean was estimated using analysis of covariance (ANCOVA) model controlling for baseline weekly itch severity score and country.

Placebo v Quilizumab

32

Pre-specified

-3.3

2-sided

The itch severity score was recorded once daily in the participant’s diary, on a scale of 0 (none) to 3 (intense). The baseline weekly itch score was the sum of the daily itch scores over the 7 days prior to randomization (Day 1 visit). The weekly itch score was the sum of the daily scores over the last 7 days prior to the time point of interest. Total weekly itch severity score ranged from 0 to 21, where higher scores indicated more intense itching. Analysis was performed on mITT population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using WOCF.

Secondary

Baseline, Week 4

The LS mean was estimated using ANCOVA model controlling for baseline weekly itch severity score and country.

Placebo v Quilizumab

32

Pre-specified

-1.5

2-sided

The urticaria activity score (UAS) was a composite diary score for the intensity of the itch and the number of wheals (hives), where the numeric severity intensity ratings were based on a scale of 0 (none) to 3 (intense/severe) for 1) the intensity of the itch; and 2) the number of wheals (hives). The UAS7 was the sum of the daily UAS over 7 days. Total UAS7 score ranged from 0 to 42, where higher scores indicated worse disease. Analysis was performed on mITT population, defined as all participants who were randomized and received at least one dose of study drug. Missing data was imputed using WOCF.

Secondary

Baseline, Week 20

The LS mean was estimated using ANCOVA model controlling for baseline weekly itch severity score and country.

Placebo v Quilizumab

32

Pre-specified

-5.8

2-sided

Number of participants positive for ATA was the number of post-baseline evaluable participants determined to have treatment-induced ATA or treatment-enhanced ATA during the study period. Participant with treatment-induced ATA was defined as a participant with a negative or missing baseline ATA result(s) and at least one positive post-baseline (P-B) ATA result. Participant with a treatment-enhanced ATA was defined as a participant with a positive ATA result at baseline who had one or more post-baseline titer results that are at least 0.60 titer units greater than the baseline titer result. Analysis was performed on participants who had at least one ATA assay results available.

Secondary

Baseline, Post-Baseline (28 weeks)

28 weeks

17.1

Placebo

Quilizumab