Polymyalgia RheumaticaPhase 2NCT05436652
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
A Phase 2 study testing SPI-62, Prednisolone 10mg and Additional prednisolone in people with Polymyalgia Rheumatica, run by Sparrow Pharmaceuticals at 10 sites in 2 countries.
Trial summary
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- SPI-62, Prednisolone 10mg and Additional prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 22 Jul 2022to 25 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Diagnosis of PMR according to EULAR/ACR classification criteria
- Absence of PMR relapse based on symptoms and acute phase markers
- Daily oral prednisolone 10mg dose that will have been stable for at least 1-week at the Baseline visit and is expected to remain stable during the treatment period
Who cannot join
- Any contraindication for prednisolone administration.
- A diagnosis or any clinical features of giant cell arteritis.
- Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- Use of other medications likely to interfere with trial assessments.
- History or diagnosis of endogenous hypercortisolism.
- Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany6 sites
Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Berlin
Internistische Praxisgemeinschaft Rheumatologie Nephrologie
Erlangen
Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
Hamburg
Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
Herne
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz
Praxis Prof. Dr. med. Herbert Kellner
Munich
Poland4 sites
NovaReuma
Bialystok
The University of Gdańsk
Gdansk
MICS Centrum Medyczne Warszawa
Warsaw
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka
Wroclaw
About this study
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
Read the detailed description
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR. Up to 6 cohorts of 12 participants could be recruited (12 to 72 participants). Each participant who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (Day -28 to Day-1), a 4-week treatment period (Day 1 to Day 28) and a follow up Period (Day 29 to Day 56). During the 4-week treatment period for the first cohort, all participants will receive prednisolone 10mg per day for 4-weeks plus SPI-62 for 2-weeks and matching placebo for 2-weeks. For cohorts 2 through 6, the dose of prednisolone co-administered with SPI-62 could be adjusted. For cohorts 5 and 6, the dose of SPI-62 could be adjusted.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- SPI-62, SPI-62 matched placebo, Prednisolone 10mg, Additional prednisolone, Additional prednisolone matched placebo
- Keywords
- polymyalgia rheumatica, PMR, Steroids, Prednisolone, glucocorticoid, glucocorticoids
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-62Drug
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
SPI-62 matched placeboDrug
Inactive tablets identical in appearance to SPI-62 tablets
Prednisolone 10mgDrug
Standard of care prednisolone
Additional prednisoloneDrug
Over encapsulated prednisolone
Additional prednisolone matched placeboDrug
Inactive capsules identical in appearance to over encapsulated prednisolone
| Study group | Role | What they receive |
|---|---|---|
| SPI-62 | Experimental | Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo. Receives: Drug: SPI-62; Drug: SPI-62 matched placebo; Drug: Prednisolone 10mg |
| SPI-62 + additional prednisolone | Experimental | Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo. Receives: Drug: SPI-62; Drug: SPI-62 matched placebo; Drug: Prednisolone 10mg; Drug: Additional prednisolone; Drug: Additional prednisolone matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte sedimentation rate
Measured: Baseline to Day 28
C-reactive protein
Measured: Baseline to Day 28
Plasma fibrinogen
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start22 Jul 2022
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparrow Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Katz, Study chair, Sparrow Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436652
- Sponsor's protocol ID
- SPI-62-CL-2003
- Status last verified
- May 2025
- First submitted
- 23 Jun 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
- ClinicalTrials.gov ID
- NCT05436652
- Acronym / sponsor ID
- SPI-62-CL-2003
- Conditions
- Polymyalgia Rheumatica
- Keywords
- polymyalgia rheumatica, PMR, Steroids, Prednisolone, glucocorticoid, glucocorticoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 29 Jun 2022 (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 will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR.
Detailed description
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in participants with PMR. Up to 6 cohorts of 12 participants could be recruited (12 to 72 participants). Each participant who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (Day -28 to Day-1), a 4-week treatment period (Day 1 to Day 28) and a follow up Period (Day 29 to Day 56). During the 4-week treatment period for the first cohort, all participants will receive prednisolone 10mg per day for 4-weeks plus SPI-62 for 2-weeks and matching placebo for 2-weeks. For cohorts 2 through 6, the dose of prednisolone co-administered with SPI-62 could be adjusted. For cohorts 5 and 6, the dose of SPI-62 could be adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI-62 | Experimental | Drug: SPI-62, Drug: SPI-62 matched placebo, Drug: Prednisolone 10mgActive drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo. |
| SPI-62 + additional prednisolone | Experimental | Drug: SPI-62, Drug: SPI-62 matched placebo, Drug: Prednisolone 10mg, Drug: Additional prednisolone, Drug: Additional prednisolone matched placeboActive drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Diagnosis of PMR according to EULAR/ACR classification criteria
- Absence of PMR relapse based on symptoms and acute phase markers
- Daily oral prednisolone 10mg dose that will have been stable for at least 1-week at the Baseline visit and is expected to remain stable during the treatment period
Key exclusion criteria (7 listed)
- Any contraindication for prednisolone administration.
- A diagnosis or any clinical features of giant cell arteritis.
- Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- Use of other medications likely to interfere with trial assessments.
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 |
|---|---|---|
| SPI-6211β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor | Drug | SPI-62, SPI-62 + additional prednisolone |
| SPI-62 matched placeboInactive tablets identical in appearance to SPI-62 tablets | Drug | SPI-62, SPI-62 + additional prednisolone |
| Prednisolone 10mgStandard of care prednisolone | Drug | SPI-62, SPI-62 + additional prednisolone |
| Additional prednisoloneOver encapsulated prednisolone | Drug | SPI-62 + additional prednisolone |
| Additional prednisolone matched placeboInactive capsules identical in appearance to over encapsulated prednisolone | Drug | SPI-62 + additional prednisolone |
Primary outcome
Erythrocyte sedimentation rate
Time frame: Baseline to Day 28
C-reactive protein
Time frame: Baseline to Day 28
Plasma fibrinogen
Time frame: Baseline to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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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.
David Katz study chair
Sparrow Pharmaceuticals
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI-62, Prednisolone 10mg and Additional prednisolone in people with Polymyalgia Rheumatica, run by Sparrow Pharmaceuticals at 10 sites in 2 countries.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Poland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte sedimentation rate (time frame: Baseline to Day 28). The study lists 3 primary outcomes in all. 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 11 May 2025.