Phase 2
N=56
A Study of Guselkumab in Participants With Systemic Sclerosis
Scleroderma, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT04683029 ↗Enrolled (actual)
56
Serious AEs
2.8%
Results posted
Oct 2024
Primary outcome: Primary: Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 — -9.5; 3.1 Score on a scale — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Guselkumab Dose 1 (Drug); Guselkumab Dose 2 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 |
-9.5; 3.1 | < 0.001 sig |
| SECONDARY Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52 |
-9.3; 2.7 | — |
| SECONDARY Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52 |
3.4; 25.9; 20.7; 77.8 | — |
| SECONDARY Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52 |
86.2; 3.7; 79.3; 3.7 | — |
| SECONDARY Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52 |
-51.9; -4.7; -26.5; -12.3 | — |
| SECONDARY Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52 |
-0.7; -0.7; -0.2; -0.4 | — |
| SECONDARY Main Study: Change From Baseline in the Measured Absolute Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 |
-0.60; -0.51; -0.35; -0.56 | — |
| SECONDARY Main Study: Change From Baseline in the Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 24 and Week 52 |
-4.57; -2.49; -1.71; -1.85 | — |
| SECONDARY Main Study: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 52 |
-0.0; 4.8; -0.1; 4.1 | — |
| SECONDARY Main Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 52 |
-0.0529; 0.3477; -0.0572; 0.1782 | — |
| SECONDARY Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 24 and Week 52 |
20; 24; 25; 26 | — |
| SECONDARY Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
23; 25 | — |
| SECONDARY Main Study: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through Week 24 and Week 52 |
0; 0; 1; 1 | — |
| SECONDARY Long-term Extension (LTE) Period: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
1; 0 | — |
| SECONDARY Main Study: Number of Participants With Adverse Events of Special Interest (AESI) Through Week 24 and Week 52 |
0; 0; 1; 2 | — |
| SECONDARY Long-term Extension (LTE) Period: Number of Participants With Adverse Events of Special Interest (AESI) |
0; 0 | — |
| SECONDARY Main Study: Serum Concentration of Guselkumab |
NA; 140.880; 22.489; 160.691; 27.968; 164.633 | — |
| SECONDARY Long-term Extension (LTE) Study: Serum Concentrations of Guselkumab |
12.167; 19.285; 12.704; 25.925; 13.835; 33.368 | — |
| SECONDARY Main Study: Number of Participants With Anti-Guselkumab Antibody |
6 | — |
| SECONDARY Long-term Extension (LTE) Study: Number of Participants With Anti-guselkumab Antibody |
6; 0 | — |
Summary
The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).
Eligibility Criteria
Inclusion criteria
- Diagnosis of systemic sclerosis (SSc) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
- Diffuse cutaneous SSc according to the LeRoy criteria that is, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
- Disease duration of ≤36 months (defined as time from first non-Raynaud phenomenon manifestation).
- Greater than or equal to (>=) 10 and less than or equal to ( = 60 percent (%) of predicted at screening
- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted (hemoglobin-corrected) at screening.
- Participants who meet 1 of the following criteria at screening: increase of >=3 mRSS units, compared with an assessment performed within the previous 2 to 6 months; Involvement of 1 new body area with an increase of >=2 mRSS units compared with an assessment performed within the previous 2 to 6 months; and Involvement of 2 new body areas with increase of >=1 mRSS units compared with the assessment within the previous 2 to 6 months
Exclusion Criteria
- History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has any known severe or uncontrolled SSc complications including hemoptysis, pulmonary hemorrhage, renal crisis
- Has an interstitial lung disease requiring oxygen therapy
- Has any rheumatic disease other than SSc such as rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), systemic lupus erythematosus, polymyositis/dermatomyositis that could interfere with assessment of SSc
- Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study)
Data sourced from ClinicalTrials.gov (NCT04683029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.