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An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02326298
Acronym
CIMPASI-1
Enrollment
234
Registered
2014-12-29
Start date
2014-12-16
Completion date
2018-10-24
Last updated
2019-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis, Psoriasis

Keywords

Certolizumab Pegol, Cimzia, Psoriasis

Brief summary

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

Detailed description

This study consists of the following Periods: * Initial Treatment Period from Week 0 to Week 16 * Maintenance Treatment Period from Week 16 to Week 48 * Open-label Treatment Period from Week 48 to Week 144 * Safety Follow-Up Period from Week 144 to Week 152

Interventions

BIOLOGICALCertolizumab Pegol

* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use

OTHERPlacebo

* Active Substance: Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use

Sponsors

UCB Biopharma S.P.R.L.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Provided informed consent * Adult men or women \>= 18 years * Chronic plaque psoriasis for at least 6 months * Baseline psoriasis activity and severity index \>= 12 and body surface area \>= 10 % and Physician's Global Assessments score \>= 3 * Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy * Other protocol-defined inclusion criteria may apply

Exclusion criteria

* Erythrodermic, guttate, generalized pustular form of psoriasis * History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol * Congestive heart failure * History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease * Concurrent malignancy or a history of malignancy as described in the protocol * History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis) * Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug (in Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug * Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study * Other protocol-defined

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16At Week 16The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16At Week 16The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Secondary

MeasureTime frameDescription
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16At Week 16The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16At Week 16The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (\>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=\<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48At Week 48The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48At Week 48The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Countries

Canada, Czechia, Germany, Hungary, United States

Participant flow

Recruitment details

The study started to enroll participants in December 2014 and concluded in October 2018 from multiple sites in Europe and North America. 234 participants were included in the Randomized Set (RS) shown in the Participant Flow.

Pre-assignment details

The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152. Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set.

Participants by arm

ArmCount
Placebo Q2W
Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
51
CZP 200 mg Q2W
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
95
CZP 400 mg Q2W
CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
88
Total Title234
Total468

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Initial Period (Week 0 to Week 16)Adverse Event00100000000000
Initial Period (Week 0 to Week 16)Adverse event after completing wk1600200000000000
Initial Period (Week 0 to Week 16)Lack of Efficacy10000000000000
Initial Period (Week 0 to Week 16)Lost to Follow-up11000000000000
Initial Period (Week 0 to Week 16)Withdrawal by Subject32000000000000
Maintenance Period (Week 16 to Week 48)Adverse Event00000001000000
Maintenance Period (Week 16 to Week 48)Did not achieve PASI50 after week 4800000200000000
Maintenance Period (Week 16 to Week 48)Lost to Follow-up00000012000000
Maintenance Period (Week 16 to Week 48)No valid reason stated by patient00000001000000
Maintenance Period (Week 16 to Week 48)Patient cannot attend visits00000100000000
Maintenance Period (Week 16 to Week 48)Patient did not achieve PASI50 response00000120400000
Maintenance Period (Week 16 to Week 48)Pregnancy00000010000000
Maintenance Period (Week 16 to Week 48)Withdrawal by Subject00000131110000
Open-label Period (Week 48 to Week 144)Adverse Event00000000000330
Open-label Period (Week 48 to Week 144)Death00000000000100
Open-label Period (Week 48 to Week 144)Did not achieve PASI5000000000000273
Open-label Period (Week 48 to Week 144)Lack of Efficacy00000000000110
Open-label Period (Week 48 to Week 144)Lost to Follow-up00000000000663
Open-label Period (Week 48 to Week 144)Protocol Violation00000000000002
Open-label Period (Week 48 to Week 144)Withdrawal by Subject00000000000721

Baseline characteristics

CharacteristicPlacebo Q2WCZP 200 mg Q2WCZP 400 mg Q2WTotal Title
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants5 Participants2 Participants13 Participants
Age, Categorical
Between 18 and 65 years
45 Participants90 Participants86 Participants221 Participants
Age, Continuous47.9 Years
STANDARD_DEVIATION 12.8
44.5 Years
STANDARD_DEVIATION 13.1
43.6 Years
STANDARD_DEVIATION 12.1
44.9 Years
STANDARD_DEVIATION 12.7
Sex: Female, Male
Female
16 Participants28 Participants28 Participants72 Participants
Sex: Female, Male
Male
35 Participants67 Participants60 Participants162 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1881 / 167
other
Total, other adverse events
95 / 18885 / 167
serious
Total, serious adverse events
14 / 18819 / 167

Outcome results

Primary

Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Time frame: At Week 16

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

ArmMeasureValue (NUMBER)
Placebo Q2W (RS)Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 164.2 percentage of participants
CZP 200 mg Q2W (RS)Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 1647.0 percentage of participants
CZP 400 mg Q2W (RS)Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 1657.9 percentage of participants
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [3.699, 109.399]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [5.687, 170.548]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [30.7, 54.86]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [41.33, 65.94]Regression, Logistic
Primary

Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Time frame: At Week 16

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

ArmMeasureValue (NUMBER)
Placebo Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 166.5 percentage of participants
CZP 200 mg Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 1666.5 percentage of participants
CZP 400 mg Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 1675.8 percentage of participants
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [6.968, 120.371]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [10.657, 195.634]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [47.92, 72.17]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [57.65, 80.99]Regression, Logistic
Secondary

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (\>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=\<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).

Time frame: At Week 16

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Placebo Q2W (RS)Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16-3.3 Scores on a scaleStandard Error 0.8
CZP 200 mg Q2W (RS)Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16-9.3 Scores on a scaleStandard Error 0.58
CZP 400 mg Q2W (RS)Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16-10.2 Scores on a scaleStandard Error 0.6
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [-8.18, -3.81]ANCOVA
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [-9.05, -4.62]ANCOVA
Secondary

Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48

The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.

Time frame: At Week 48

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

ArmMeasureValue (NUMBER)
Placebo Q2W (RS)Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 4852.7 percentage of participants
CZP 200 mg Q2W (RS)Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 4869.5 percentage of participants
Secondary

Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Time frame: At Week 48

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

ArmMeasureValue (NUMBER)
Placebo Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 4867.2 percentage of participants
CZP 200 mg Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 4887.1 percentage of participants
Secondary

Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Time frame: At Week 16

Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

ArmMeasureValue (NUMBER)
Placebo Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 160.4 percentage of participants
CZP 200 mg Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 1635.8 percentage of participants
CZP 400 mg Q2W (RS)Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 1643.6 percentage of participants
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [27.56, 58.71]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [5.717, 235.193]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.p-value: <0.000197.5% CI: [7.88, 324.988]Regression, Logistic
Comparison: The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.95% CI: [20.85, 49.87]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026