A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

nemolizumab (CIM331)

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥18 and ≤65 years of age at the time of consent.
Patients with Atopic Dermatitis
Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion Criteria:

Serological evidence of hepatitis B virus or hepatitis C virus infection
Known human immunodeficiency virus infection
Ongoing treatment with specific or non-specific hyposensitization therapy for AD
Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
Pregnant or lactating women.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group1

Group2

Group3

Group4

Group5

Arm Description

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Part A: Placebo Part B: nemolizumab (CIM331)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

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).

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).

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).

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).

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).

Full Information

NCT ID

NCT01986933

First Posted

October 31, 2013

Last Updated

January 18, 2022

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01986933

Brief Title

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Official Title

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

264 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group1

Arm Type

Experimental

Arm Description

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Arm Title

Group2

Arm Type

Experimental

Arm Description

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Arm Title

Group3

Arm Type

Experimental

Arm Description

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Arm Title

Group4

Arm Type

Experimental

Arm Description

Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)

Arm Title

Group5

Arm Type

Experimental

Arm Description

Part A: Placebo Part B: nemolizumab (CIM331)

Intervention Type

Drug

Intervention Name(s)

nemolizumab (CIM331)

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12

Description

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).

Time Frame

baseline to Week 12

Secondary Outcome Measure Information:

Title

Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)

Description

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).

Time Frame

baseline to Week 12 (Part A)

Title

Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)

Description

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).

Time Frame

baseline to Week 12 (Part A), up to Week 64 (Part B)

Title

Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)

Description

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).

Time Frame

baseline to Week 12 (Part A)

Title

Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)

Description

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).

Time Frame

baseline to Week 12 (Part A), up to Week 64 (Part B)

Title

Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)

Description

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).

Time Frame

baseline to Week 12 (Part A)

Title

Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)

Description

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).

Time Frame

baseline to Week 12 (Part A), up to Week 64 (Part B)

Title

Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)

Description

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).

Time Frame

baseline to Week 12 (Part A)

Title

Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)

Description

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).

Time Frame

baseline to Week 12 (Part A), up to Week 64 (Part B)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: ≥18 and ≤65 years of age at the time of consent. Patients with Atopic Dermatitis Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit Exclusion Criteria: Serological evidence of hepatitis B virus or hepatitis C virus infection Known human immunodeficiency virus infection Ongoing treatment with specific or non-specific hyposensitization therapy for AD Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization. Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay. Pregnant or lactating women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryosuke Mihara

Organizational Affiliation

Chugai Pharmaceutical

Official's Role

Study Director

Facility Information:

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92122

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28226

Country

United States

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29753033

Citation

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.

Results Reference

derived

PubMed Identifier

28249150

Citation

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.

Results Reference

derived

Atopic Dermatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial