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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568162
Other study ID # GBR 830-204
Secondary ID 2018-000783-29
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2018
Est. completion date August 3, 2021

Study information

Verified date July 2022
Source Ichnos Sciences SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.


Recruitment information / eligibility

Status Completed
Enrollment 462
Est. completion date August 3, 2021
Est. primary completion date August 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female subjects aged =18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria. - Atopic dermatitis involvement of =10% of body surface area at screening and baseline. - EASI score of =12 at screening or =16 at baseline. - IGA score of =3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) - Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity =3 over the previous 24 hours. Exclusion Criteria: - Pregnant or lactating women. - Prior treatment with ISB 830 - Treatment with biologics - Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline - Active chronic or acute infection requiring systemic treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ISB 830 - Part 1 Group 1
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 2
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 1 Group 3
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 1 Group 4
Subcutaneous injection (SC) every 2 weeks
ISB 830 - Part 2 Group 5
Subcutaneous injection (SC) every 2 weeks
Placebo - Part 2 Group 6
Subcutaneous injection (SC) every 2 weeks

Locations

Country Name City State
Canada Ichnos Investigational Site 202 Calgary Alberta
Canada Ichnos Investigational Site 211 Drummondville Quebec
Canada Ichnos Investigational Site 214 Hamilton Ontario
Canada Ichnos Investigational Site 204 Markham Ontario
Canada Ichnos Investigational Site 206 Ottawa Ontario
Canada Ichnos Investigational Site 208 Ottawa Ontario
Canada Ichnos Investigational Site 201 Richmond Hill Ontario
Canada Ichnos Investigational Site 203 Surrey British Columbia
Canada Ichnos Investigational Site 207 Winnipeg Manitoba
Czechia Ichnos Investigational Site 404 Brno Brno-mesto
Czechia Ichnos Investigational Site 402 Náchod Královéhradecký Kraj
Czechia Ichnos Investigational Site 401 Ostrava
Czechia Ichnos Investigational Site 405 Pardubice
Czechia Ichnos Investigational Site 403 Praha Praha 3
Czechia Ichnos Investigational Site 407 Praha 1
Czechia Ichnos Investigational Site 406 Svitavy
Germany Ichnos Investigational Site 304 Berlin
Germany Ichnos Investigational Site 319 Berlin
Germany Ichnos Investigational Site 326 Berlin
Germany Ichnos Investigational Site 322 Bielefeld Nordrhein-Westfalen
Germany Ichnos Investigational Site 318 Bochum Nordrhein-Westfalen
Germany Ichnos Investigational Site 302 Dresden Sachsen
Germany Ichnos Investigational Site 309 Dresden Sachsen
Germany Ichnos Investigational Site 311 Erlangen Bayern
Germany Ichnos Investigational Site 313 Friedrichshafen Baden-Württemberg
Germany Ichnos Investigational Site 308 Hamburg
Germany Ichnos Investigational Site 310 Hamburg
Germany Ichnos Investigational Site 305 Langenau Baden-Württemberg
Germany Ichnos Investigational Site 315 Lübeck Schleswig-Holstein
Germany Ichnos Investigational Site 314 Osnabrück Niedersachsen
Poland Ichnos Investigational Site 519 Gdynia Pomorskie
Poland Ichnos Investigational Site 520 Gdynia Pomorskie
Poland Ichnos Investigational Site 517 Iwonicz-Zdrój Podkarpackie
Poland Ichnos Investigational Site 503 Katowice
Poland Ichnos Investigational Site 510 Krakow Malopolskie
Poland Ichnos Investigational Site 511 Krakow Malopolskie
Poland Ichnos Investigational Site 501 Kraków Malopolskie
Poland Ichnos Investigational Site 502 Kraków Malopolskie
Poland Ichnos Investigational Site 505 Kraków
Poland Ichnos Investigational Site 514 Poznan Wielkopolskie
Poland Ichnos Investigational Site 518 Poznan Wielkopolskie
Poland Ichnos Investigational Site 508 Skarzysko-Kamienna
Poland Ichnos Investigational Site 513 Szczecin Zachodniopomorskie
Poland Ichnos Investigational Site 506 Warszawa Mazowieckie
Poland Ichnos Investigational Site 507 Warszawa
Poland Ichnos Investigational Site 509 Warszawa Mazowieckie
Poland Ichnos Investigational Site 512 Warszawa Mazowieckie
Poland Ichnos Investigational Site 521 Warszawa Mazowieckie
Poland Ichnos Investigational Site 504 Wroclaw Dolnoslaskie
United States Ichnos Investigational Site 129 Birmingham Alabama
United States Ichnos Investigational Site 142 Brandon Florida
United States Ichnos Investigational Site 106 Bridgeport Connecticut
United States Ichnos Investigational Site 132 Chattanooga Tennessee
United States Ichnos Investigational Site 120 Clovis California
United States Ichnos Investigational Site 146 Danbury Connecticut
United States Glenmark Investigational Site 102 Forest Hills New York
United States Ichnos Investigational Site 143 Fort Myers Florida
United States Ichnos Investigational Site 133 Hazleton Pennsylvania
United States Ichnos Investigational Site 119 Houston Texas
United States Ichnos Investigational Site 148 Lake City Florida
United States Ichnos Investigational Site 141 Lake Worth Florida
United States Ichnos Investigational Site 144 Las Vegas Nevada
United States Ichnos Investigational Site 114 Medford Oregon
United States Ichnos Investigational Site 123 Miami Florida
United States Ichnos Investigational Site 140 Miami Florida
United States Ichnos Investigational Site109 New Orleans Louisiana
United States Ichnos Investigational Site 115 Newnan Georgia
United States Ichnos Investigational Site 103 Newport News Virginia
United States Ichnos Investigational Site 147 Ormond Beach Florida
United States Ichnos Investigational Site 138 Pflugerville Texas
United States Ichnos Investigational Site 122 Philadelphia Pennsylvania
United States Ichnos Investigational Site 112 Plainfield Indiana
United States Ichnos Investigational Site 131 Richmond Virginia
United States Ichnos Investigational Site 105 Rolling Hills Estates California
United States Ichnos Investigational Site 126 Saint Louis Missouri
United States Ichnos Investigational Site 116 San Antonio Texas
United States Ichnos Investigational Site 139 Savannah Georgia
United States Ichnos Investigational Site 136 Spokane Washington
United States Ichnos Investigational site 101 Tampa Florida
United States Ichnos Investigational Site 135 Tampa Florida
United States Ichnos Investigational Site 117 Verona New Jersey
United States Ichnos Investigational Site 110 Waco Texas
United States Ichnos Investigational Site 125 West Des Moines Iowa

Sponsors (2)

Lead Sponsor Collaborator
Ichnos Sciences SA Glenmark Pharmaceuticals S.A.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16 In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD. Baseline, Week 16
Secondary Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16 In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD. Baseline, Week 16
Secondary Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of = 2 Points at Week 16 The IGA is an assessment scale used in clinical studies to determine severity of AD based on a 5-point scale ranging from 0 (clear) to 4 (severe/very severe). Baseline, Week 16
Secondary Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of = 4 From Baseline at Week 16 Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. Baseline, Week 16
Secondary Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16 In EASI, 4 disease characteristics of AD are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the 4 body regions (Head and neck, trunk, arms, and legs). The assigned percentages of BSA for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD. Baseline, Week 16
Secondary Percent Change From Baseline in SCORAD Score at Week 16 SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of BSA affected; b) subjective symptom visual analog assessments for pruritis ( 0 [no itching] to 3 [severe itching]) and sleep disturbance (0 [no sleep disturbance] to 3 [severe sleep disturbance]); and c) 6 disease intensity assessments [dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe). Baseline, Week 16
Secondary Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. Baseline, Week 16
Secondary Change From Baseline in Global Individual Signs Score (GISS) at Week 16 GISS assesses AD lesions for erythema, excoriations, lichenification and infiltration/papulation. Each component is rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe) according to the EASI grading severity. Total score ranges from 0 to 12 (no disease to most severe disease, respectively). Baseline, Week 16
Secondary Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16 The HADS is a 14-item questionnaire, with 7 items related to anxiety (HADS-A) and 7 items related to depression (HADS-D). Each item is scored from 0 to 3; scores for each subscale range from 0 to 21, with higher scores indicating more distress. For each subscale, scores 7 or lower are considered normal, 8 to 10 are borderline, and 11 or higher indicate clinical anxiety or depression. Baseline, Week 16
Secondary Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16 The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). Baseline, Week 16
Secondary Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16 For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent". Baseline, Week 16
Secondary Percentage Change From Baseline in PGA of Disease and Treatment at Week 16 For PGA of disease, participants rated their overall wellbeing on a 5-point Likert scale from 0 (poor) to 4 (excellent). Participants were asked: "Considering all the ways in which your disease affects you, indicate how well you are doing." Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent." For PGA of treatment, participants rated their satisfaction with the study treatment on a 5-point Likert scale from 0 (poor) to 4 (excellent). Subjects were asked: "How would you rate the way your disease responded to the study medication?" Response choices were: "Poor"; "Fair"; "Good"; "Very Good"; "Excellent". Baseline, Week 16
Secondary Number of Missed Work or School Days at Week 16 Participants who were employed or enrolled in school were asked to report the number of sick leave and/or missed school days due to AD (eg, versus due to an accident) in the last 4 weeks. Week 16
Secondary Maximum Observed Serum Concentration (Cmax) of ISB 830 Cmax is the maximum concentration of ISB 830 observed in serum Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on Day 85
Secondary Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau) AUC0-tau is the area under the curve from time zero to the end of the dosing interval of ISB 830. Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on Day 85
Secondary Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16 Participants with ADA were those with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period (up to Week 16). Treatment-emergent ADA referred to percentage of the total number of evaluable participants who were ADA-negative at baseline but developed ADA following biologic drug administration. Treatment-boosted ADA referred to percentage of the total number of evaluable participants who were ADA positive at baseline with at least 4-fold increase in ADA titer after biologic drug administration. Baseline through Week 16
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