Trial · NCT04426890
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | participants | NUMBER |
| SECONDARY | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | score on a scale | MEAN |
| SECONDARY | Time to Minimally Important Difference (MID) in ISS7 by Week 12 | Up to Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | in Weeks | MEDIAN |
| SECONDARY | Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | score on a scale | MEAN |
| SECONDARY | Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With UAS7 of ≤ 6 Points and Complete Responders in Weekly Urticaria Activity Score at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Angioedema-Free Days From Week 4 to Week 12 | Week 4 to 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | percentage of Angioedema-Free Days | MEAN |
| SECONDARY | Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | Number of Tablets/Week | MEAN |
| SECONDARY | Change From Baseline in Number of Tablets/Week of Rescue Therapy at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | Number of Tablets/Week | MEAN |
| SECONDARY | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 12 | Week 12 | Analysis was performed based on mITT Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT Set was defined as all randomly assigned patients who received at least 1 full dose of either of the study drugs during Treatment Period I. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Overall Chronic Urticaria Quality of Life Questionnaire Score (CU-Q2oL) Score at Week 24 | Week 24 | Analysis was performed based on mITT-TP2 Subset which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The mITT-TP2 Subset was defined as all patients in the mITT Set who underwent the second randomization and received at least 1 full dose of either of the study drugs during Treatment Period II. | score on a scale | MEAN |
| SECONDARY | Trough Serum Concentration (Ctrough) of Omalizumab at Week 12 | Week 12 | Analysis was performed based on PK Set which had different definition with RAN set for disposition table.~This table presents the actual number of patients who had a result and were included in the analysis.~The PK Set was defined as all patients who received at least 1 full dose of either of the study drugs during Treatment Period I and had at least 1 post-treatment PK result prior to dosing at Week 12. | ug/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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