Trial · NCT01986933
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
NCT01986933, Phase 2, Completed, Chugai Pharmaceutical; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of CIM331 for Atopic Dermatitis Patients. Trials, record NCT01986933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
- NCT number
- NCT01986933
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 264 participants, actual
- Lead sponsor
- Chugai Pharmaceutical
- Conditions
- Atopic Dermatitis
- Interventions
- nemolizumab (CIM331), Placebo
- First posted
- 2013-11-19
- Last updated
- 2022-01-25
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | baseline to 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). |
| Secondary | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | baseline to Week 12 (Part A) | 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). |
| Secondary | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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). |
| Secondary | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | baseline to Week 12 (Part A) | 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). |
| Secondary | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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). |
| Secondary | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | baseline to Week 12 (Part A) | 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). |
| Secondary | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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). |
| Secondary | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | baseline to Week 12 (Part A) | 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). |
| Secondary | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | baseline to Week 12 | 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. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | baseline to Week 12 (Part A) | 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. | percentage change from baseline | MEAN |
| SECONDARY | Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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. | percentage change from baseline | MEAN |
| SECONDARY | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | baseline to Week 12 (Part A) | 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. | percentage change from baseline | MEAN |
| SECONDARY | Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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. | percentage change from baseline | MEAN |
| SECONDARY | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | baseline to Week 12 (Part A) | 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. | change from baseline | MEAN |
| SECONDARY | Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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. | change from baseline | MEAN |
| SECONDARY | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | baseline to Week 12 (Part A) | 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. | percentage change from baseline | MEAN |
| SECONDARY | Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | baseline to Week 12 (Part A), up to Week 64 (Part B) | 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. | percentage change from baseline | MEAN |
Source ClinicalTrials.gov
Results by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Placebo (Part A) | -20.07 | 95% Confidence Interval -29.94 to -10.21 | percentage change | |
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | -41.46 | 95% Confidence Interval -51.21 to -31.71 | percentage change | |
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | -61.24 | 95% Confidence Interval -71.13 to -51.35 | percentage change | |
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | -60.46 | 95% Confidence Interval -69.98 to -50.95 | percentage change | |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Placebo (Part A) | Week 4 | -12.12 | Standard Deviation 40.00 | percentage change from baseline |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Week 4 | -26.89 | Standard Deviation 44.48 | percentage change from baseline |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | Week 4 | -35.70 | Standard Deviation 44.29 | percentage change from baseline |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | Week 4 | -33.86 | Standard Deviation 34.14 | percentage change from baseline |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Placebo (Part A) | Week 8 | -21.82 | Standard Deviation 47.00 | percentage change from baseline |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | Week 8 | -25.17 | Standard Deviation 51.79 | percentage change from baseline |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled (Part A) | STARTED | Placebo | 53 | |
| Placebo-controlled (Part A) | STARTED | Nemoliozumab (0.1 mg/kg) Q4W | 53 | |
| Placebo-controlled (Part A) | STARTED | Nemoliozumab (0.5 mg/kg) Q4W | 54 | |
| Placebo-controlled (Part A) | STARTED | Nemoliozumab (2.0 mg/kg) Q4W | 52 | |
| Placebo-controlled (Part A) | STARTED | Nemoliozumab (2.0 mg/kg) Q8W | 52 | |
| Placebo-controlled (Part A) | COMPLETED | Placebo | 44 | |
| Placebo-controlled (Part A) | COMPLETED | Nemoliozumab (0.1 mg/kg) Q4W | 44 | |
| Placebo-controlled (Part A) | COMPLETED | Nemoliozumab (0.5 mg/kg) Q4W | 45 | |
| Placebo-controlled (Part A) | COMPLETED | Nemoliozumab (2.0 mg/kg) Q4W | 45 | |
| Placebo-controlled (Part A) | COMPLETED | Nemoliozumab (2.0 mg/kg) Q8W | 38 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events351
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 | Nasopharyngitis | Infections and infestations | Placebo (Part A) | 8 | 53 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | 9 | 53 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | 6 | 54 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | 5 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (2.0 mg/kg) Q8W (Part A) | 7 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B) | 15 | 53 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) | 14 | 54 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | 15 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | 12 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo (Part A) | 6 | 53 |
1 to 10 of 351Source ClinicalTrials.gov
See all 351 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Part A) | 0 | 53 |
| Total, all-cause mortality | Nemoliozumab (0.1 mg/kg) Q4W (Part A) | 0 | 53 |
| Total, all-cause mortality | Nemoliozumab (0.5 mg/kg) Q4W (Part A) | 0 | 54 |
| Total, all-cause mortality | Nemoliozumab (2.0 mg/kg) Q4W (Part A) | 0 | 52 |
| Total, all-cause mortality | Nemoliozumab (2.0 mg/kg) Q8W (Part A) | 0 | 52 |
| Total, all-cause mortality | Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B) | 0 | 53 |
| Total, all-cause mortality | Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B) | 0 | 54 |
| Total, all-cause mortality | Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B) | 0 | 52 |
| Total, all-cause mortality | Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B) | 0 | 52 |
| Total, other adverse events | Placebo (Part A) | 27 | 53 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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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GET https://conductscience.org/api/trials/v1/NCT01986933/results?page=2