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A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M1095 (Sonelokimab)
Placebo
Secukinumab
Sponsored by
Bond Avillion 2 Development LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female subjects between 18 and 75 years of age.
  2. Moderate to severe plaque-type psoriasis for at least 6 months.
  3. Subject is a candidate for systemic biologic therapy.
  4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
  5. Subject is able to comply with the study procedures.
  6. Subject must provide informed consent.

Exclusion Criteria (Main):

  1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
  2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
  3. Laboratory abnormalities at screening, as defined in the study protocol.
  4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
  5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
  6. History of suicidal thoughts within 12 months.

Sites / Locations

  • Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

M1095 (Sonelokimab) 30mg

M1095 (Sonelokimab) 60mg

M1095 (Sonelokimab) 120mg - regimen 1

M1095 (Sonelokimab) 120mg - regimen 2

Placebo / M1095 (Sonelokimab) 120mg

Secukinumab

Arm Description

M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.

Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Outcomes

Primary Outcome Measures

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

Secondary Outcome Measures

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline

Full Information

First Posted
December 20, 2017
Last Updated
August 2, 2021
Sponsor
Bond Avillion 2 Development LP
Collaborators
Avillion LLP
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1. Study Identification

Unique Protocol Identification Number
NCT03384745
Brief Title
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Official Title
A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bond Avillion 2 Development LP
Collaborators
Avillion LLP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M1095 (Sonelokimab) 30mg
Arm Type
Experimental
Arm Description
M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Arm Title
M1095 (Sonelokimab) 60mg
Arm Type
Experimental
Arm Description
M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
Arm Title
M1095 (Sonelokimab) 120mg - regimen 1
Arm Type
Experimental
Arm Description
M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
Arm Title
M1095 (Sonelokimab) 120mg - regimen 2
Arm Type
Experimental
Arm Description
M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
Arm Title
Placebo / M1095 (Sonelokimab) 120mg
Arm Type
Placebo Comparator
Arm Description
Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.
Arm Title
Secukinumab
Arm Type
Active Comparator
Arm Description
Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.
Intervention Type
Drug
Intervention Name(s)
M1095 (Sonelokimab)
Other Intervention Name(s)
Sonelokimab
Intervention Description
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo contains no active drug.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
Cosentyx®
Intervention Description
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Primary Outcome Measure Information:
Title
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
Description
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.
Time Frame
Week 12, as compared to Week 0 (baseline)
Secondary Outcome Measure Information:
Title
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
Description
PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
Time Frame
Week 12, as compared to Week 0 (baseline)
Title
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
Description
PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
Time Frame
Week 12, as compared to baseline
Title
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
Description
PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline
Time Frame
Week 12, as compared to Week 0 (baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects between 18 and 75 years of age. Moderate to severe plaque-type psoriasis for at least 6 months. Subject is a candidate for systemic biologic therapy. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline. Subject is able to comply with the study procedures. Subject must provide informed consent. Exclusion Criteria (Main): Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed). Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C. Laboratory abnormalities at screening, as defined in the study protocol. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks. History of suicidal thoughts within 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Kim Papp
Organizational Affiliation
Probity Medical Research Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigative Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigative Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Investigative Site
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Facility Name
Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigative Site
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Investigative Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Investigative Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Investigative Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Investigative Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Investigative Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Investigative Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Investigative Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Investigative Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Investigative Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Investigative Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Investigative Site
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Investigative Site
City
Náchod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
Investigative Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Investigative Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Investigative Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Investigative Site
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Investigative Site
City
Uherské Hradiště
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Investigative Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Facility Name
Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Investigative Site
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Investigative Site
City
Darmstadt
ZIP/Postal Code
64297
Country
Germany
Facility Name
Investigative Site
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigative Site
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Investigative Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Investigative Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Investigative Site
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Investigative Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Investigative Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Investigative Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Investigative Site
City
Orosháza
ZIP/Postal Code
5900
Country
Hungary
Facility Name
Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Investigative Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Investigative Site
City
Katowice
ZIP/Postal Code
40-060
Country
Poland
Facility Name
Investigative Site
City
Lublin
ZIP/Postal Code
20-314
Country
Poland
Facility Name
Investigative Site
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Investigative Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Investigative Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Investigative Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Investigative Site
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Investigative Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33894834
Citation
Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2. Erratum In: Lancet. 2021 Jun 5;397(10290):2150.
Results Reference
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A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

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