Trial · NCT04426890
To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
NCT04426890, Phase 3, Completed, Celltrion; results first posted 2025-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria. Trials, record NCT04426890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04426890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria
- NCT number
- NCT04426890
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 634 participants, actual
- Lead sponsor
- Celltrion
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- CT-P39, EU-approved Xolair
- First posted
- 2020-06-11
- Last updated
- 2025-07-29
- Other registries' IDs
- eudract:2020-000952-36
- Results first posted
- 2025-07-29
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | Week 12 | The primary efficacy evaluation was comparison of mean change from baseline in ISS7 of 300 mg of CT-P39 (Arm 1) and 300 mg of Xolair (Arm 2) at Week 12, calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The analysis was conducted by analysis of covariance (ANCOVA). The ANCOVA model included the treatment group as a fixed effect and baseline ISS7, body weight on Day 1 and country as covariates. |
| Primary | Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Week 12 | The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency was not calculated due to the assumption of parallel-line assay not being met. A parallel-line assay assumes that dose-efficacy response relationships are linear and parallel on log-dose scale which requires the equal slope in the regression model used to estimate relative potency. However, the slopes of the two treatment groups were estimated to be different, indicating a violation of the parallelism assumption. As a result, the relative potency was not computed. |
| Secondary | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Week 12 | The change from baseline in ISS7 at Week 12 was calculated as ISS7 at Week 12 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. The relative potency based on the CFB of ISS7 at Week 12 was not calculated due to assumption of parallel-line assay not being met. |
| Secondary | Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 24 | Week 24 | The change from baseline in ISS7 at Week 24 was calculated as ISS7 at Week 24 minus the baseline ISS7. The ISS was recorded twice daily (morning and evening) in the patient eDiary, on scale of 0 (none) to 3 (severe) points. The daily ISS is the average of the morning and evening scores and the ISS7 is the sum of the daily ISS over 7 days. The ISS7 can range from 0 to 21. The higher scores mean a worse outcome. |
| Secondary | Time to Minimally Important Difference (MID) in ISS7 by Week 12 | Up to Week 12 | Time to MID response was the time (in weeks) from Day 1 to the study week when reduction of 5 points or more from baseline for ISS7 was first achieved up to Week 12. If a patient failed to achieve an MID response up to Week 12 or terminated the study prior to Week 12 without achieving MID response, the patient was censored at the date (in weeks) of the last non-missing ISS7 evaluation. Time to MID was estimated by Kaplan-Meier method. The lower result means a better outcome. |
| Secondary | Percentage of Minimally Important Difference (MID) Responders in ISS7 at Week 12 | Week 12 | Number of patients who achieved MID response at Week 12 were presented. MID response is a change from baseline in ISS7 of ≤ -5. If a patient had missing weekly scores for the given week the patient was classified as a non-responder. The higher percentage means a better outcome. |
| Secondary | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 | Week 12 | The change from baseline in HSS7 at Week 12 was calculated as HSS7 at Week 12 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. |
| Secondary | Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 24 | Week 24 | The change from baseline in HSS7 at Week 24 was calculated as HSS7 at Week 24 minus the baseline HSS7. The HSS was counted twice daily (morning and evening) in the patient eDiary, on a scale of 0 (none) to 3 (intense) points. The daily HSS is the average of the morning and evening scores, and the HSS7 is the sum of the daily HSS over 7 days. HSS7 can range from 0 to 21. The higher scores mean a worse outcome. |
| Secondary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12 | Week 12 | The change from baseline in UAS7 at Week 12 was calculated as UAS7 at Week 12 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. |
| Secondary | Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 24 | Week 24 | The change from baseline in UAS7 at Week 24 was calculated as UAS7 at Week 24 minus the baseline UAS7. The UAS was calculated as the sum of the ISS and the HSS by diary-based documentation. The sum of the scores represented disease severity on a scale from 0 (minimum) to 6 (maximum). The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS over 7 days. UAS7 can range from 0 to 42. The higher scores mean a worse outcome. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | Arm 1 | -9.25 | Standard Error 0.787 | score on a scale | |
| Therapeutic Equivalence Based on Change From Baseline in ISS7 at Week 12 in 300 mg Groups | Arm 2 | -9.96 | Standard Error 0.791 | score on a scale | |
| Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Arm 1 | NA | 90% Confidence Interval NA to NA | participants | |
| Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Arm 2 | NA | 90% Confidence Interval NA to NA | participants | |
| Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Arm 3 | NA | 90% Confidence Interval NA to NA | participants | |
| Relative Potency of CT-P39 Compared With Xolair Based on Change From Baseline in ISS7 at Week 12 | Arm 4 | NA | 90% Confidence Interval NA to NA | participants | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Arm 1 | -9.31 | Standard Deviation 6.20 | score on a scale | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Arm 2 | -9.99 | Standard Deviation 6.18 | score on a scale | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Arm 3 | -9.56 | Standard Deviation 5.87 | score on a scale | |
| Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 | Arm 4 | -8.73 | Standard Deviation 6.65 | score on a scale |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 1 | 204 | |
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 2 | 205 | |
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 2-1 | 0 | |
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 2-2 | 0 | |
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 3 | 107 | |
| Treatment Period 1 (Week 0 to Week 12) | STARTED | Arm 4 | 103 | |
| Treatment Period 1 (Week 0 to Week 12) | COMPLETED | Arm 1 | 187 | |
| Treatment Period 1 (Week 0 to Week 12) | COMPLETED | Arm 2 | 192 | |
| Treatment Period 1 (Week 0 to Week 12) | COMPLETED | Arm 2-1 | 0 | |
| Treatment Period 1 (Week 0 to Week 12) | COMPLETED | Arm 2-2 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events390
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Arm 1/Treatment Period 1 | 5 | 203 | |
| other | COVID-19 | Infections and infestations | Arm 2/ Treatment Period 1 | 7 | 205 | |
| other | COVID-19 | Infections and infestations | Arm 3/ Treatment Period 1 | 4 | 107 | |
| other | COVID-19 | Infections and infestations | Arm 4/ Treatment Period 1 | 1 | 103 | |
| other | COVID-19 | Infections and infestations | Arm 1/Treatment Period 2 | 5 | 187 | |
| other | COVID-19 | Infections and infestations | Arm 2-1/ Treatment Period 2 | 2 | 96 | |
| other | COVID-19 | Infections and infestations | Arm 2-2/Treatment Period 2 | 1 | 96 | |
| other | COVID-19 | Infections and infestations | Arm 3/ Treatment Period 2 | 2 | 101 | |
| other | COVID-19 | Infections and infestations | Arm 4/ Treatment Period 2 | 3 | 98 | |
| other | COVID-19 | Infections and infestations | Arm 1/Follow-up Period | 2 | 203 |
1 to 10 of 390Source ClinicalTrials.gov
See all 390 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1/Treatment Period 1 | 0 | 203 |
| Total, all-cause mortality | Arm 2/ Treatment Period 1 | 0 | 205 |
| Total, all-cause mortality | Arm 3/ Treatment Period 1 | 0 | 107 |
| Total, all-cause mortality | Arm 4/ Treatment Period 1 | 0 | 103 |
| Total, all-cause mortality | Arm 1/Treatment Period 2 | 1 | 187 |
| Total, all-cause mortality | Arm 2-1/ Treatment Period 2 | 0 | 96 |
| Total, all-cause mortality | Arm 2-2/Treatment Period 2 | 0 | 96 |
| Total, all-cause mortality | Arm 3/ Treatment Period 2 | 0 | 101 |
| Total, all-cause mortality | Arm 4/ Treatment Period 2 | 0 | 98 |
| Total, all-cause mortality | Arm 1/Follow-up Period | 0 | 203 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04426890
GET https://conductscience.org/api/trials/v1/NCT04426890/registered?page=2