NCT01986933

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

November 22, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

October 31, 2013

Results QC Date

October 22, 2021

Last Update Submit

January 18, 2022

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

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

    baseline to Week 12 (Part A)

  • 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)

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

    baseline to Week 12 (Part A)

  • 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)

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

    baseline to Week 12 (Part A)

  • +3 more secondary outcomes

Study Arms (5)

Group1

EXPERIMENTAL

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

Drug: nemolizumab (CIM331)

Group2

EXPERIMENTAL

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

Drug: nemolizumab (CIM331)

Group3

EXPERIMENTAL

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

Drug: nemolizumab (CIM331)

Group4

EXPERIMENTAL

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

Drug: nemolizumab (CIM331)

Group5

EXPERIMENTAL

Part A: Placebo Part B: nemolizumab (CIM331)

Drug: nemolizumab (CIM331)Other: Placebo

Interventions

nemolizumab (CIM331)DRUG
Group1Group2Group3Group4Group5
PlaceboOTHER
Group5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Anniston, Alabama, 36207, United States

Location

Unknown Facility

San Diego, California, 92122, United States

Location

Unknown Facility

Miami, Florida, 33142, United States

Location

Unknown Facility

Alpharetta, Georgia, 30022, United States

Location

Unknown Facility

Arlington Heights, Illinois, 60005, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Indianapolis, Indiana, 46256, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Louisville, Kentucky, 40217, United States

Location

Unknown Facility

Bay City, Michigan, 48706, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Charlotte, North Carolina, 28226, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Charleston, South Carolina, 29407, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

College Station, Texas, 77845, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

  • 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.

    PMID: 29753033DERIVED

  • 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.

    PMID: 28249150DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Clinical trials information
Organization
Chugai Pharmaceutical
clinical-trials@chugai-pharm.co.jp

Study Officials

  • Ryosuke Mihara

    Chugai Pharmaceutical

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 19, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2016

Last Updated

January 25, 2022

Results First Posted

November 22, 2021

Record last verified: 2022-01

Locations

US(18)