OSE Stage for Scleroderma, Diffuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metroplex Clinical Research Centre, Dallas, TX
Scleroderma, Diffuse+3 More
RO7303509 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. The MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 9 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety.

Eligible Conditions

  • Scleroderma, Diffuse
  • Systemic; Sclerosis, Progressive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Scleroderma, Diffuse

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Up to approximately 17 months

Year 3
MAD and OSE Stage: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against RO7303509
Day 113
MAD Stage: Area Under the Concentration vs Time Curve (AUC) of RO7303509
MAD Stage: Half-Life (t1/2) of RO7303509
MAD Stage: Time to Maximum Concentration (Tmax) of RO7303509
MAD Stage: Total Clearance (CL) of RO7303509
MAD Stage: Volume of Distribution (V) of RO7303509
Day 113
MAD Stage: Maximum Serum Concentration (Cmax) of RO7303509
Month 17
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Test Results
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Scleroderma, Diffuse

Trial Design

2 Treatment Groups

OSE Stage
1 of 2
MAD Stage
1 of 2
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: OSE Stage · Has Placebo Group · Phase 1

OSE Stage
Drug
Experimental Group · 1 Intervention: RO7303509 · Intervention Types: Drug
MAD StageExperimental Group · 2 Interventions: Placebo, RO7303509 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 17 months
Closest Location: Metroplex Clinical Research Centre · Dallas, TX
Photo of Dallas  1Photo of Dallas  2Photo of Dallas  3
2019First Recorded Clinical Trial
1 TrialsResearching Scleroderma, Diffuse
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have diffuse cutaneous systemic sclerosis (dcSSc), ≥ 15 modified Rodnan Skin Score (mRSS) units or with limited cutaneous systemic sclerosis (lcSSc), ≥ 9 mRSS units.
You are able to roll over into the OSE.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.