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Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

Study acronym: ATHENA-SSc-ILD
StatusActive, Not Recruiting
PhasePhase 2
Started2022-03-29
View on ClinicalTrials.gov ↗

Amendment history

2026-09-23
Completion moved earlier: 2029-07-31 → 2026-11-16
2026-05-13
Study Status v40
Primary completion dateestimated 2026-04-30→confirmed 2026-04-16
2025-10-15
Study Identification, Study Status, Study Design v39
Primary completion date2026-05-30→2026-04-30
Enrollment targetestimated 152→confirmed 154
2025-04-18
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v38
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 95 of 95 sites
2025-04-16
Study Status, Contacts/Locations v37
Primary completion date2026-03-31→2026-05-30
Completion date2029-06-30→2029-07-31
Start date2022-07-13→2022-03-29
Study sites92→95
Show 36 earlier versions
2025-03-07
Study Identification, Study Status, Contacts/Locations, IPDSharing v36
Study sites91→92
2025-02-07
Study Status, Contacts/Locations v35
Study sites86→91
2024-12-20
Study Status v34
Primary completion date2025-12-19→2026-03-31
Completion date2028-12-30→2029-06-30
2024-12-17
Study Status, Contacts/Locations v33
Study sites81→86
2024-11-21
2 amendments v31-v32
2 re-verifications since 2024-11-11, no change to tracked fields
2024-10-24
Study Status, Contacts/Locations v30
Study sites80→81
2024-10-09
Study Status, Contacts/Locations v29
Study sites79→80
2024-10-01
Study Status, Contacts/Locations v28
Study sites75→79
2024-09-10
Study Identification, Study Status, Contacts/Locations v27
Study sites74→75
2024-08-08
Study Status, Contacts/Locations v26
Study sitesdetails revised at 4 of 74 sites
2024-07-18
Study Status, Contacts/Locations, References v25
Study sitesdetails revised at 1 of 74 sites
2024-05-03
Study Status, Contacts/Locations v24
Study sitesdetails revised at 2 of 74 sites
2024-04-24
Study Status, Contacts/Locations v23
Study sitesdetails revised at 1 of 74 sites
2024-04-04
Study Status, Contacts/Locations v22
Completion date2028-12-29→2028-12-30
Study sitesdetails revised at 1 of 74 sites
2024-01-12
Study Status v21
Start date2022-03-29→2022-07-13
2023-12-20
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v20
Primary completion date2024-03-29→2025-12-19
Completion date2024-06-28→2028-12-29
Start date2022-02-22→2022-03-29
Enrollment target100→152
Study sites73→74
InterventionsCompanion diagnostic ( CDx) (Device), PRA023 IV (Drug), Placebo (Drug)→Companion diagnostic ( CDx) (Diagnostic Test), Placebo (Drug), Tulisokibart (Drug)
Eligibility criteria+34 characters
Inclusion Criteria: ConfirmedHas confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago. DiffuseHas diffuse cutaneous scleroderma SystemicHas systemic sclerosis related interstitial lung disease confirmed by HR [...] of lung for carbon monoxide (DLCO)≥ 45% of predicted normal StableIf on background therapy, meets stable dosing ofrequirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) orOR azathioprine, as welland corticosteroids Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptab [...] [...]
Secondary endpoints4 to 5 entries
Change offrom FVC Annual rate of changeBaseline in percentFVC predictedat FVCWeek 50 Change from Baseline in highHigh-resolutionResolution computerComputer tomographyTomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50 ChangePercentage of Participants with an Improvement in Americanthe CollegeRevised of Rheumatology CombinedComposite Response Index in Systemic Sclerosis (ACR CRISS) Score at Week 50 Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50 Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quali [...]
Primary endpoints2 to 4 entries
Change from Baseline in the Annual changeRate of forcedChange vitalin capacityForced Vital Capacity (FVC) at Week 50 IncidenceNumber of AE,Participants SAEwho andDiscontinue AE leadingdue to discontinuationan AE Number of Participants who Experience a Serious Adverse Event (SAE) Number of Participants who Experience an Adverse Event (AE)
Study title+37 characters
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
2023-11-14
Study Identification, Study Status v19
Re-verified, no change to tracked fields
2023-10-16
Study Status, Contacts/Locations v18
Study sites71→73
2023-07-14
Study Status, Contacts/Locations v17
Study sites70→71
2023-05-19
Study Status, Contacts/Locations v16
Study sites66→70
2023-04-11
Study Status, Contacts/Locations v15
Study sites64→66
2023-03-15
Study Status, Contacts/Locations v14
Study sites58→64
2023-02-23
Study Status, Eligibility, Contacts/Locations v13
Study sites55→58
Eligibility criteria+12 characters
[...] on monoxide (DLCO)≥ 45% of predicted normal Stable dosing of nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) or azathiop [...]
2023-02-10
Study Status, Contacts/Locations v12
Study sites52→55
2023-01-06
Study Status, Contacts/Locations v11
Study sites43→52
2022-11-21
Study Status, Contacts/Locations v10
Study sites38→43
2022-11-04
Study Status, Contacts/Locations v9
Study sites32→38
2022-10-21
Study Status, Contacts/Locations v8
Study sites26→32
2022-09-23
Study Status, Contacts/Locations v7
Study sites20→26
2022-08-19
Study Status, Contacts/Locations v6
Study sites14→20
2022-07-12
Study Status, Contacts/Locations v5
Study sites11→14
2022-06-03
Study Status, Contacts/Locations v4
Study sites6→11
2022-05-24
Study Status, Contacts/Locations v3
Study sites5→6
2022-05-12
Study Status, Contacts/Locations v2
Study sites1→5
2022-03-28
Study Status, Sponsor/Collaborators v1
Collaborators-19 characters
PPD Development, LP
2022-03-07
Original filing
Merck (MSD)
401 trials monitored
See 24 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
Trial Details
NCT Number NCT05270668
Lead Sponsor Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Enrollment 154 participants
Start Date 2022-03-29
Primary Completion 2026-04-16 (estimated)
Study Completion 2026-11-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-22