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Not yet recruitingNCT07925619LIFTUpdated Nov 9, 2026

Efficacy and Safety Study of L608 in Patients With Systemic Sclerosis-associated Digital Ulcers

A Phase 2 interventional study of L608 and Placebo in Systemic Sclerosis, sponsored by Pharmosa Biopharm Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Pharmosa Biopharm Inc. · Phase 2, Interventional, and Treatment

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial is designed to evaluate the efficacy and safety of L608 compared to placebo in patients with SSc-DU.

Read the detailed description

This trial is designed to evaluate the efficacy and safety of L608 compared to placebo in patients with SSc-DU, with the primary objective of exploring the effect of L608 on reducing the time to healing of the cardinal DU.

The trial utilizes a double-blind, placebo-controlled, parallel group design. Approximately 40 eligible participants will be enrolled and randomized 1:1 to L608 or placebo groups at baseline.

02

Conditions studied

  • Systemic Sclerosis

Keywords

  • Systemic Sclerosis
  • Digital Ulcers
03

In context

Scleroderma, Systemic

610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.

This study's planned enrollment of 40 is close to the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Pharmosa Biopharm Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Diagnosed with systemic sclerosis per ACR/EULAR 2013 criteria.
  2. Presence of at least one visible, painful digital ulcer.
  3. Participants aged ≥18 years.

Key Exclusion Criteria:

  1. DUs not primarily ischemic in origin.
  2. Other rheumatic diseases are permitted if SSc is the predominant condition associated with DUs.
  3. Active gangrene (within 3 months) or active DU infection requiring treatment (within 1 month) prior to screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    L608

    Drug: L608

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugL608

    Participants will receive L608 TID over 28 consecutive days.

  • DrugPlacebo

    Participants will receive Placebo TID over 28 consecutive days.

06

What researchers measure

Primary outcomes

  1. Time to healing of the cardinal DU

    Time to healing of the cardinal DU compared with placebo

    Time frame: up to 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07925619
Lead sponsor
Pharmosa Biopharm Inc.
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 9, 2026

Study contacts

Pei Kan, PhD
Contact
peikan@pharmosa.com.tw
+886-2-2782-7561 ext. 102
Sydney Chuang
Contact
sydney@pharmosa.com.tw
+886-2-2782-7561 ext. 110

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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