Polymyalgia RheumaticaPhase 1NCT06281236
A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR)
A Phase 1 study testing Prednisolone and SPI-62 in people with Polymyalgia Rheumatica, run by Sparrow Pharmaceuticals at 5 sites in Germany.
Trial summary
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited. 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?
- Prednisolone and SPI-62
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesGermany
- Study dates
- 22 Feb 2022to 25 Apr 2025
- Phase
- Phase 1
- 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 European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist
- Absence of PMR relapse based on symptoms and acute phase markers
- Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1
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 other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period
- 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
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Emovis Gmbh
Berlin
Klinische Forschung Hannover Mitte GmbH/Pratia
Hanover, 30159
Universitätsmedizin der Johannes Gutenburg Universität Mainz
Mainz, 55131
Klinikum der Universität München
München, 80336
Klinische Forschung Schwerin GmbH/Pratia
Schwerin, 19055
About this study
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Read the detailed description
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial.
Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16
Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Prednisolone, SPI-62
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
SPI-62Drug
SPI-62 administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| prednisolone + SPI-62 | Experimental | Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16. Receives: Drug: Prednisolone; Drug: SPI-62 |
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 posted28 Feb 2024
- Study start22 Feb 2022
- Primary completion25 Mar 2025
- Study completion25 Apr 2025
Why it stopped: lack of enrollment
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT06281236
- Sponsor's protocol ID
- SPI-62-CL-1002
- Status last verified
- May 2025
- First submitted
- 20 Feb 2024
- Last updated
- 16 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 16 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 in Participants With Polymyalgia Rheumatica (PMR)
- ClinicalTrials.gov ID
- NCT06281236
- Acronym / sponsor ID
- SPI-62-CL-1002
- Conditions
- Polymyalgia Rheumatica
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 28 Feb 2024 (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 an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Detailed description
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial.
Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16
Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prednisolone + SPI-62 | Experimental | Drug: Prednisolone, Drug: SPI-62Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16. |
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 European League Against Rheumatism and American College of Rheumatology classification criteria confirmed by a rheumatologist
- Absence of PMR relapse based on symptoms and acute phase markers
- Daily oral prednisolone 10, 12.5, 15, 17.5, or 20 mg dose that will have been stable for at least 7 days prior to Day 1
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 other than oral prednisolone within specified intervals prior to Day 1 and during the treatment period
- 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 |
|---|---|---|
| PrednisolonePrednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers. | Drug | prednisolone + SPI-62 |
| SPI-62SPI-62 administered once daily. | Drug | prednisolone + SPI-62 |
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 was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prednisolone and SPI-62 in people with Polymyalgia Rheumatica, run by Sparrow Pharmaceuticals at 5 sites in Germany.
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: stopped early, as of the sponsor's last update on 16 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 5 sites in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: lack of enrollment). Results are not available in the source record.
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 16 May 2025.