Diffuse Cutaneous Systemic Sclerosis

7
Pipeline Programs
3
Companies
8
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
5
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Corbus Pharmaceuticals
2 programs
1
1
Lenabasum 5 mgPhase 31 trial
JBT-101Phase 21 trial
Active Trials
NCT02465437Terminated42Est. Dec 2020
NCT03398837Terminated365Est. Dec 2020
Amgen
AmgenTHOUSAND OAKS, CA
3 programs
1
2
HZN-825Phase 21 trial
HZN-825 BIDPhase 21 trial
TEPEZZAPhase 12 trials
Active Trials
NCT04478994Terminated3Est. Dec 2022
NCT06563856Completed37Est. May 2021
NCT05626751Terminated174Est. Feb 2025
+1 more trials
CSL Behring
CSL BehringIL - Bradley
2 programs
2
IgPro10Phase 21 trial
IgPro20Phase 21 trial
Active Trials
NCT04138485Withdrawn0Est. Sep 2020
NCT04137224Completed27Est. May 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Corbus PharmaceuticalsLenabasum 5 mg
AmgenHZN-825
AmgenHZN-825 BID
CSL BehringIgPro10
CSL BehringIgPro20
Corbus PharmaceuticalsJBT-101
AmgenTEPEZZA
AmgenTEPEZZA

Clinical Trials (8)

Total enrollment: 949 patients across 8 trials

NCT03398837Corbus PharmaceuticalsLenabasum 5 mg

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Start: Dec 2017Est. completion: Dec 2020365 patients
Phase 3Terminated
NCT05626751AmgenHZN-825

An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Start: Nov 2022Est. completion: Feb 2025174 patients
Phase 2Terminated
NCT04781543AmgenHZN-825 BID

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Start: Nov 2022Est. completion: Feb 2025301 patients
Phase 2Terminated
NCT04138485CSL BehringIgPro10

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

Start: Dec 2019Est. completion: Sep 20200
Phase 2Withdrawn
NCT04137224CSL BehringIgPro20

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Start: Sep 2019Est. completion: May 202227 patients
Phase 2Completed
NCT02465437Corbus PharmaceuticalsJBT-101

Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis

Start: Aug 2015Est. completion: Dec 202042 patients
Phase 2Terminated
NCT04478994AmgenTEPEZZA

A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Start: Nov 2021Est. completion: Dec 20223 patients
Phase 1Terminated
NCT06563856AmgenTEPEZZA

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

Start: Sep 2020Est. completion: May 202137 patients
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
3 companies competing in this space