Arthritis, Psoriatic
Conditions
Keywords
Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis
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.
Interventions
DRUGSonelokimab
randomized treatment; parallel group
DRUGPlacebo
randomized treatment; parallel-group
DRUGAdalimumab
randomized treatment; parallel-group
Sponsors
MoonLake Immunotherapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is ≥18 years of age; 2. 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; 3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); 4. Participant has either current active PsO or a dermatologist confirmed history of PsO; 5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit; 6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; 7. Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
Exclusion criteria
1. Participant with known hypersensitivity to sonelokimab or any of its excipients; 2. Participant with known hypersensitivity to adalimumab or any of its excipients; 3. Participant who has previously failed on anti-interleukin (IL)-17 therapy; 4. Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy; 5. Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit; 6. Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA; 7. Participant who has a diagnosis of arthritis mutilans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 | At Week 12 | The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12 | At Weeks 2, 4, 8, and 12 | The ACR20 response criteria was a response of at least 20% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 20% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. ACR20 response rate at Week 12 was analyzed as a key secondary outcome measure. |
| Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline | At Weeks 4, 8, and 12 | The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI90 response was defined as greater than or equal to 90% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. PASI90 response at Week 12 was analyzed as a key secondary outcome measure. |
| Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8 | At Weeks 2, 4, and 8 | The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. |
| Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12 | At Weeks 2, 4, 8, and 12 | The ACR70 response criteria was a response of at least 70% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 70% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. |
| Percentage of Participants Achieving Minimal Disease Activity at Week 12 | At Week 12 | Minimal disease activity was defined as meeting 5 of the following 7 criteria: tender joint count (68 joints) ≤1; swollen joint count (66 joints) ≤1; psoriasis area and severity index ≤1 or psoriasis affecting ≤1% of body surface area; PtAAP ≤15 on a VAS (0 = no pain to 100 = severe pain); PtGADA ≤20 on a VAS (0 = very well to 100 = very poor); HAQ-DI ≤0.5 (overall score ranging from 0 \[mild disability\] to 3 \[very severe disability\]); and Leeds Enthesitis Index (LEI) ≤1 (overall score ranging from 0 to 6, with higher scores indicating greater disease severity). An NRI method was used for missing data. |
| Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline | At Week 12 | The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI75 response was defined as greater than or 75% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. |
| Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline | At Week 12 | The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI100 response was defined as 100% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. |
| Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12 | Baseline and Week 12 | The mNAPSI is a tool to assess psoriatic nail involvement. Three groups of features (pitting, onycholysis, and oil-drop dyshromia and crumbling) for each fingernail are graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) are graded as either present (1) or absent (0) in each fingernail. The total score was calculated by summing the score for each feature and each fingernail and ranged from 0 to 130, with higher scores indicating greater nail disease. A negative change from baseline indicated an improvement in nail disease. |
Countries
Bulgaria, Czechia, Estonia, Germany, Hungary, Poland, Spain, United States
Contacts
STUDY_DIRECTORMD
MoonLake Immunotherapeutics AG
Participant flow
Recruitment details
Participants were enrolled in 8 countries in the United States (US) and European Union (EU). The trial included a screening period of up to 4 weeks, a 12-week placebo-controlled treatment period (Part A), a 12-week active treatment period (Part B), and safety follow-up period of 8 weeks (± 7 days) after last dose of trial treatment (or 12 weeks \[± 7 days\] for participants enrolled in Czech Republic). In the US, only Part A was conducted, whereas in the EU, Parts A and B were conducted.
Pre-assignment details
In Part A, participants were randomized (1:1:1:1:1) to 1 of 5 treatment groups to receive sonelokimab (3 dosing regimens), matching placebo, or adalimumab. In Part B, participants were allocated to treatment based upon clinical response at end of Part A (Week 12).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 12.7 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 204 Participants |
| Race/Ethnicity, Customized Not reported | 3 Participants |
| Race/Ethnicity, Customized White | 39 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 | 0 / 41 | 0 / 43 | 0 / 42 | 0 / 82 | 0 / 97 | 0 / 47 |
| other Total, other adverse events | 6 / 39 | 3 / 41 | 5 / 41 | 4 / 43 | 6 / 42 | 12 / 82 | 13 / 97 | 7 / 47 |
| serious Total, serious adverse events | 0 / 39 | 0 / 41 | 1 / 41 | 0 / 43 | 0 / 42 | 1 / 82 | 4 / 97 | 0 / 47 |
Outcome results
None listed