DermatomyositisPhase 2FROGNCT05833711
Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
A Phase 2 study testing Froniglutide in people with Dermatomyositis and Polymyositis, run by Immunoforge Co. Ltd. at 1 site in South Korea.
Trial summary
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study") Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Dermatomyositis, Polymyositis, Idiopathic Inflammatory Myopathies
- What is being tested?
- Froniglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2023to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IIM (DM or polymyositis [PM]) as per Bohan and Peter classification criteria
- MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 >125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
- On treatment with standard of care (immunosuppressants and/or corticosteroids) for >12 weeks and on stable therapy for at least 4 weeks
- Severe muscle damage (myositis damage index [MDI] >7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
- Clinically significant renal/hepatic impairment
- Severe interstitial lung disease requiring supportive oxygen therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Seoul Hospital
Seoul, 04763
Dae-Hyun Yoo, Professor
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")
- Being tested
- Froniglutide, Placebo
- Medical subject headings
- Dermatomyositis, Polymyositis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FroniglutideDrug
Also called PF1801
SC Weekly Injection
PlaceboDrug
SC Weekly Injection
| Study group | Role | What they receive |
|---|---|---|
| Froniglutide 50 mg | Experimental | Froniglutide (PF1801) 50 mg will be administered subcutaneously once a week. Receives: Drug: Froniglutide |
| Froniglutide 70 mg | Experimental | Froniglutide (PF1801) 70 mg will be administered subcutaneously once a week. Receives: Drug: Froniglutide |
| Placebo | Placebo comparator | Matching placebo will be administered subcutaneously once a week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMACS-TIS Moderate Improvement at Week 24
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
Measured: Week 24
Secondary outcomes (1)
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24
Proportion of subjects who achieve minimal improvement (≥20) from baseline in IMACS TIS at Week 4, 8, 12, 16, and 24
Measured: Week 4, 8, 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start5 Sep 2023
- Primary completionMar 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunoforge Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833711
- Sponsor's protocol ID
- PF1801-CL-202
- Acronym
- FROG
- Status last verified
- Sep 2023
- First submitted
- 16 Apr 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)
- ClinicalTrials.gov ID
- NCT05833711
- Acronym / sponsor ID
- FROG / PF1801-CL-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Immunoforge Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Froniglutide 50 mg | Experimental | Drug: FroniglutideFroniglutide (PF1801) 50 mg will be administered subcutaneously once a week. |
| Froniglutide 70 mg | Experimental | Drug: FroniglutideFroniglutide (PF1801) 70 mg will be administered subcutaneously once a week. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered subcutaneously once a week. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of IIM (DM or polymyositis [PM]) as per Bohan and Peter classification criteria
- MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 >125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
- On treatment with standard of care (immunosuppressants and/or corticosteroids) for >12 weeks and on stable therapy for at least 4 weeks
- Severe muscle damage (myositis damage index [MDI] >7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
- Clinically significant renal/hepatic impairment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FroniglutideAlso: PF1801SC Weekly Injection | Drug | Froniglutide 50 mg, Froniglutide 70 mg |
| PlaceboSC Weekly Injection | Drug | Placebo |
Primary outcome
IMACS-TIS Moderate Improvement at Week 24
Time frame: Week 24
Proportion of subjects who achieve moderate improvement (≥40) from baseline in IMACS TIS at Week 24
1 secondary outcome
IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24
Time frame: Week 4, 8, 12, 16, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Froniglutide in people with Dermatomyositis and Polymyositis, run by Immunoforge Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minhee Song (+82-4946-8465, mini@immunoforge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMACS-TIS Moderate Improvement at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.