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Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Primary Purpose

Arthritis, Psoriatic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sonelokimab
Placebo
Adalimumab
Sponsored by
MoonLake Immunotherapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic focused on measuring Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis

Eligibility Criteria

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

Inclusion Criteria: Participant is ≥18 years of age; Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit; Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); Participant has either current active PsO or a dermatologist confirmed history of PsO; Participant tests negative for rheumatoid factor (RF) at the Screening Visit; Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information. Exclusion Criteria: Participant with known hypersensitivity to sonelokimab or any of its excipients; Participant with known hypersensitivity to adalimumab or any of its excipients; Participant who has previously failed on anti-interleukin (IL)-17 therapy; Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy; Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit; Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA; Participant who has a diagnosis of arthritis mutilans

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

sonelokimab dose regimen 1

sonelokimab dose regimen 2

sonelokimab dose regimen 3

Placebo

adalimumab

Arm Description

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3

Subjects randomized to this arm will receive placebo

Subjects randomized to this arm will receive adalimumab

Outcomes

Primary Outcome Measures

Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Proportion of participants who achieve ACR50 compared with baseline

Secondary Outcome Measures

Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)
Proportion of participants who achieve ACR20 compared with baseline
Psoriasis Area and Severity Index (PASI) 90
Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria
Proportion of participants who achieve ACR70 compared with baseline
Leeds Enthesitis Index (LEI)
Proportion of participants with resolution of enthesitis (LEI = 0)
Leeds Dactylitis Index (LDI)
Change from baseline for Leeds Dactylitis Index
Modified Nail Psoriasis Severity Index (mNAPSI)
Change from baseline for mNAPSI
Psoriasis Area and Severity Index (PASI) 100
Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline

Full Information

First Posted
November 28, 2022
Last Updated
August 11, 2023
Sponsor
MoonLake Immunotherapeutics AG
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1. Study Identification

Unique Protocol Identification Number
NCT05640245
Brief Title
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
Official Title
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MoonLake Immunotherapeutics AG

4. Oversight

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

5. Study Description

Brief Summary
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Detailed Description
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
Keywords
Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
sonelokimab dose regimen 1
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1
Arm Title
sonelokimab dose regimen 2
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2
Arm Title
sonelokimab dose regimen 3
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive placebo
Arm Title
adalimumab
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive adalimumab
Intervention Type
Drug
Intervention Name(s)
Sonelokimab
Other Intervention Name(s)
M1095
Intervention Description
randomized treatment; parallel group
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
randomized treatment; parallel-group
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
randomized treatment; parallel-group
Primary Outcome Measure Information:
Title
Response Rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Description
Proportion of participants who achieve ACR50 compared with baseline
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Response Rate of participants achieving at least a 20% improvement in the American College of Rheumatology criteria (ACR20)
Description
Proportion of participants who achieve ACR20 compared with baseline
Time Frame
Week 2, 4, 8, 12
Title
Psoriasis Area and Severity Index (PASI) 90
Description
Proportion of participants who achieve PASI90 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Time Frame
Week 4, 8, 12
Title
Response rate of participants achieving at least a 70% improvement in the American College of Rheumatology criteria
Description
Proportion of participants who achieve ACR70 compared with baseline
Time Frame
Weeks 2, 4, 8, 12
Title
Leeds Enthesitis Index (LEI)
Description
Proportion of participants with resolution of enthesitis (LEI = 0)
Time Frame
Weeks 4, 8, 12
Title
Leeds Dactylitis Index (LDI)
Description
Change from baseline for Leeds Dactylitis Index
Time Frame
Weeks 4, 8, 12
Title
Modified Nail Psoriasis Severity Index (mNAPSI)
Description
Change from baseline for mNAPSI
Time Frame
Week 12
Title
Psoriasis Area and Severity Index (PASI) 100
Description
Proportion of participants who achieve PASI100 in the subgroup of participants with psoriasis involving at least 3% body surface area at baseline
Time Frame
Weeks 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is ≥18 years of age; Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit; Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); Participant has either current active PsO or a dermatologist confirmed history of PsO; Participant tests negative for rheumatoid factor (RF) at the Screening Visit; Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information. Exclusion Criteria: Participant with known hypersensitivity to sonelokimab or any of its excipients; Participant with known hypersensitivity to adalimumab or any of its excipients; Participant who has previously failed on anti-interleukin (IL)-17 therapy; Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy; Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit; Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA; Participant who has a diagnosis of arthritis mutilans
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Reich, M.D., Ph.D. (equ.)
Organizational Affiliation
MoonLake Immunotherapeutics AG
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Clinical Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Clinical Site
City
Pleven
ZIP/Postal Code
5803
Country
Bulgaria
Facility Name
Clinical Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Clinical Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Clinical Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Clinical Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Clinical Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Clinical Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Clinical Site
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Clinical Site
City
Tartu
ZIP/Postal Code
20708
Country
Estonia
Facility Name
Clinical Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Clinical Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Clinical Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Clinical Site
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Clinical Site
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Clinical Site
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-077
Country
Poland
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Clinical Site
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Clinical Site
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Clinical Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Clinical Site
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Clinical Site
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Clinical Site
City
Kraków
ZIP/Postal Code
30-727
Country
Poland
Facility Name
Clinical Site
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Clinical Site
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Clinical Site
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Facility Name
Clinical Site
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Clinical Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Clinical Site
City
Swidnica
ZIP/Postal Code
58-100
Country
Poland
Facility Name
Clinical Site
City
Warsaw
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Clinical SIte
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Clinical Site
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Clinical Site
City
Madrid
ZIP/Postal Code
28100
Country
Spain
Facility Name
Clinical Site
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Clinical Site
City
Santiago De Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Clinical Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

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