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To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) |
|
| Group2 | Experimental | Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) |
|
| Group3 | Experimental | Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) |
|
| Group4 | Experimental | Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) |
|
| Group5 | Experimental | Part A: Placebo Part B: nemolizumab (CIM331) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nemolizumab (CIM331) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryosuke Mihara | Chugai Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29753033 | Derived | Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10. | |
| 28249150 |
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Patient eligibility was assessed during the screening period (Day -28 to Day -8). If all eligibility criteria were met, the patient entered a 7-day run-in period (Day -7 to Day -1) during which all prohibited treatments were discontinued. Baseline assessments were performed until randomization on Day 1.
The patients were enrolled at 57 investigational sites in the UK, Germany, Poland, Japan, and the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Placebo-to-active period (Part B ) (up to Week 64): Patients randomized to placebo group in Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. Nemoliozumab was given subcutaneously every 4 weeks for 52 weeks. Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Placebo-controlled (Part A) |
|
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| Other |
|
| baseline to Week 12 (Part A) |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) |
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A) |
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) |
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A) |
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) |
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | baseline to Week 12 (Part A) |
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | baseline to Week 12 (Part A), up to Week 64 (Part B) |
| San Diego |
| California |
| 92122 |
| United States |
| Miami | Florida | 33142 | United States |
| Alpharetta | Georgia | 30022 | United States |
| Arlington Heights | Illinois | 60005 | United States |
| Chicago | Illinois | 60612 | United States |
| Indianapolis | Indiana | 46256 | United States |
| Louisville | Kentucky | 40202 | United States |
| Louisville | Kentucky | 40217 | United States |
| Bay City | Michigan | 48706 | United States |
| New York | New York | 10016 | United States |
| Charlotte | North Carolina | 28226 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97239 | United States |
| Charleston | South Carolina | 29407 | United States |
| Charleston | South Carolina | 29425 | United States |
| College Station | Texas | 77845 | United States |
| Norfolk | Virginia | 23507 | United States |
| Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490. |
| FG001 | Nemoliozumab (0.1 mg/kg) Q4W | The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B ) (up to Week 64): Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. Placebo-to-active period (Part B) (up to Week 64): Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. |
| FG002 | Nemoliozumab (0.5 mg/kg) Q4W | The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B ) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. Placebo-to-active period (Part B) (up to Week 64): Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. |
| FG003 | Nemoliozumab (2.0 mg/kg) Q4W | The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B ) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. Placebo-to-active period (Part B) (up to Week 64): Patients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. |
| FG004 | Nemoliozumab (2.0 mg/kg) Q8W | The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B ) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. Placebo-to-active period (Part B) (up to Week 64): Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B. |
|
| COMPLETED |
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| NOT COMPLETED |
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|
| Active-to-active (Part B) |
|
|
| Placebo-to-active (Part B) |
|
|
The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus Visual Analogue Scale (VAS) at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Part A) | Data from patients randomized to this group in Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| BG001 | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Data from patients randomized to this group in Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| BG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from patients randomized to this group in Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| BG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from patients randomized to this group in Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| BG004 | Nemoliozumab (2.0 mg/kg) Q8W (Part A) | Data from patients randomized to this group in Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | Centimetre |
| |||||||||||||||
| Weight | Mean | Standard Deviation | Kilogram |
| |||||||||||||||
| Weight Category | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | Kilogram per square metre |
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| Body Mass Index Category | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population. | Posted | Least Squares Mean | 95% Confidence Interval | percentage change | baseline to Week 12 |
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| Secondary | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A) |
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| Secondary | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A), up to Week 64 (Part B) |
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| Secondary | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A) |
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| Secondary | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A), up to Week 64 (Part B) |
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| Secondary | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population. | Posted | Mean | Standard Deviation | change from baseline | baseline to Week 12 (Part A) |
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| Secondary | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available. | Posted | Mean | Standard Deviation | change from baseline | baseline to Week 12 (Part A), up to Week 64 (Part B) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A) |
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| Secondary | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline to Week 12 (Part A), up to Week 64 (Part B) |
|
baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period
The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality.
Note: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | 53 | 1 | 53 | 27 | 53 |
| EG001 | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | 53 | 1 | 53 | 29 | 53 |
| EG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | 54 | 0 | 54 | 23 | 54 |
| EG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. | 0 | 52 | 3 | 52 | 27 | 52 |
| EG004 | Nemoliozumab (2.0 mg/kg) Q8W (Part A) | Data from Part A and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. | 0 | 52 | 5 | 52 | 25 | 52 |
| EG005 | Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | 53 | 3 | 53 | 37 | 53 |
| EG006 | Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | 54 | 3 | 54 | 35 | 54 |
| EG007 | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | 52 | 4 | 52 | 33 | 52 |
| EG008 | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A, Part B and Safety Follow-up period were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. | 0 | 52 | 9 | 52 | 35 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials information | Chugai Pharmaceutical | clinical-trials@chugai-pharm.co.jp |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612881 | nemolizumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Pregnancy |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Others (not classified above reasons) |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| 20 -< 30 years |
|
| 30 -< 40 years |
|
| 40 -< 50 years |
|
| 50 -< 60 years |
|
| > 60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >- 60 kg |
|
| >- 25 kg/m^2 |
|
| ANCOVA |
| <0.0001 |
Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained. |
| Mean Difference (Final Values) |
| -41.16 |
| Standard Error of the Mean |
| 7.10 |
| 2-Sided |
| 95 |
| -55.17 |
| -27.15 |
| Superiority |
| ANCOVA | <0.0001 | Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained. | Mean Difference (Final Values) | -40.39 | Standard Error of the Mean | 6.95 | 2-Sided | 95 | -54.11 | -26.67 | Superiority |
Data from Part A were analyzed.
Placebo-controlled period (Part A) (Day 1 to Week 12):
Patients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.
| OG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
|
|
| OG001 | Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG002 | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
|
|
| OG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
|
|
| Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) |
Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG002 | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
|
|
| OG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
|
|
| OG001 |
| Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) |
Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG002 | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
|
|
| OG002 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Data from Part A were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. |
|
|
Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG002 | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
| OG003 | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | Data from Part A and Part B were analyzed. Placebo-controlled period (Part A) (Day 1 to Week 12): Patients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8. Active-to-active period (Part B) (up to Week 64): Patients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B. |
|
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