Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
72
Countries
2
Sites
9
Polymyalgia rheumatica (PMR)
To identify whether a prednisolone dose adjustment is necessary to provide equivalent efficacy when administered with SPI-62 in subjects with PMR and, if so, estimate the adjustment.
Key facts
- Sponsor
- Sparrow Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 26 Jul 2022 → 25 Apr 2025
- Decision date (initial)
- 2024-11-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sparrow Pharmaceuticals, Inc., United States
External identifiers
- EU CT number
- 2024-517406-29-00
- EudraCT number
- 2022-000299-20
- WHO UTN
- U1111-1312-2326
- ClinicalTrials.gov
- NCT05436652
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Pharmacogenetic, Therapy, Pharmacokinetic, Safety, Pharmacogenomic, Efficacy, Dose response
To identify whether a prednisolone dose adjustment is necessary to provide equivalent efficacy when administered with SPI-62 in subjects with PMR and, if so, estimate the adjustment.
Secondary objectives 3
- 1. To observe whether SPI-62 mitigates prednisolone toxicity in subjects with PMR and, if so, estimate the appropriate dose to administer in combination withprednisolone
- 2. To characterize the pharmacological activity of SPI-62 in subjects with PMR
- 3. To report the safety of SPI-62 in subjects with PMR treated with prednisolone
Conditions and MedDRA coding
Polymyalgia rheumatica (PMR)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10036099 | Polymyalgia rheumatica | 100000004859 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Assessment for participant's eligibility for the trial; duration up to 28 days
|
Not Applicable | None | ||
| 2 | Treatment Period In this trial participants are on a stable dose of prednisolone 10 mg for a minimum of 1 week prior to the Baseline Visit. The test treatment from Day 1 until Day 28 is prednisolone co-administered with SPI-62 and the control treatment is prednisolone with placebo for SPI-62. Co-administered doses of prednisolone and SPI-62 will differ between 6 cohorts.
Participants in Cohort 1 will remain at prednisolone 10 mg for a total of at least 5 weeks. The daily prednisolone dose is increased by 5 mg day in Cohort 2, by 10 mg Cohort 3, and by 20 mg in Cohort 4 during SPI-62 6 mg co-administration. The dose for SPI-62 is the same for Cohorts 1-4 (6 mg per day). For Cohorts 5 and 6, all participants in a cohort will receive the same total prednisolone dose (20 mg per day) during SPI-62 administration. In Cohort 5, all participants will receive 2 mg per day of SPI-62. In Cohort 6, all participants will receive one loading dose of 4 mg at the first day of the SPI-62 period and on the remaining days 0.6 mg of SPI-62. Participants will get SPI-62 for two weeks and placebo for two weeks. Participants will not know the order of these treatments. The same applies for the additional prednisolone.
|
2 | Single | [{"id":106134,"code":1,"name":"Subject"}] | SPI-62: Treatment with SPI-62 for two weeks SPI-62 matching placebo: Treatment with SPI-62 matching placebo for two weeks |
| 3 | Follow-up period One follow-up visit will be performed on Day 56 [±7 days]
|
2 | Single | [{"id":106136,"code":1,"name":"Subject"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Written informed consent.
- 2. Diagnosis of PMR according to EULAR/ACR classification criteria
- 3. Absence of PMR relapse based on symptoms and acute phase markers.
- 4. Daily oral prednisolone 10 mg 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.
Exclusion criteria 7
- 1. Any contraindication for prednisolone administration.
- 2. A diagnosis or any clinical features of giant cell arteritis.
- 3. Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
- 4. Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
- 5. Use of other medications likely to interfere with trial assessments.
- 6. History or diagnosis of endogenous hypercortisolism.
- 7. 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein
Secondary endpoints 1
- Oral glucose tolerance test glucose area under the concentration‑time curve, osteocalcin, urinary 11β-hydroxysteroid dehydrogenase type 1 ratio
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10172793 · Product
- Active substance
- Clofutriben
- Substance synonyms
- 4-{5-[2-(4-Chloro-2,6-difluorophenoxy)propan-2-yl]-4-methyl-4H-1,2,4-triazol-3-yl}-3-fluorobenzamide, SPI-62, ASP3662
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 6.0 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- SPARROW PHARMACEUTICALS, INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD11632043 · Product
- Active substance
- Clofutriben
- Substance synonyms
- 4-{5-[2-(4-Chloro-2,6-difluorophenoxy)propan-2-yl]-4-methyl-4H-1,2,4-triazol-3-yl}-3-fluorobenzamide, SPI-62, ASP3662
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 6.0 mg milligram(s)
- Max total dose
- 84 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- SPARROW PHARMACEUTICALS, INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD1752711 · Product
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 560 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 40631.01.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Prednisolone is over-encapsulated to maintain the single blind.
Placebo 2
Capsule, hard for oral use as placebo for prednisolone.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Film-coated tablet for oral use as placebo for Clofutriben (SPI-62).
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sparrow Pharmaceuticals Inc.
- Sponsor organisation
- Sparrow Pharmaceuticals Inc.
- Address
- 920 Southwest 6th Avenue
- City
- Portland
- Postcode
- 97204-1239
- Country
- United States
Scientific contact point
- Organisation
- Sparrow Pharmaceuticals Inc.
- Contact name
- Scientific contact point
Public contact point
- Organisation
- Sparrow Pharmaceuticals Inc.
- Contact name
- Scientific contact point
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| FGK Clinical Research GmbH ORG-100008669
|
Munich, Germany | Other |
| SGS Analytics Germany GmbH ORG-100013017
|
Munich, Germany | Laboratory analysis |
| FGK Clinical Research Sp. z o.o. ORG-100051092
|
Warsaw, Poland | On site monitoring, Code 11, Code 12, Code 2 |
| Marmon Biostatistics ORL-000003216
|
Seattle, United States | Code 10 |
| Precision for Medicine GmbH ORG-100044456
|
Berlin, Germany | Laboratory analysis |
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 60 | 6 |
| Poland | Ended | 12 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Universitätsklinikum der Ruhr-Universität Bochum
Rheumazentrum Ruhrgebiet am Marienhospital, Claudiusstrasse 45, 44649, Herne
Internistische Praxisgemeinschaft Rheumatologie
Nephrologie, Möhrendorferstraße 1c, 91056, Erlangen
Charité - Universitätsmedizin Berlin
Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie - Campus Charité Mitte, Luisenstraße 13, Berlin
Universitätsmedizin der Johannes Gutenberg Universität
Rheumatologie, Rheumatologie, Langenbeckstraße 1, Mainz
Gemeinschaftspraxis Prof. Dr. med. Herbert Kellner
Praxis Prof. Dr. Kellner, Romanstraße 9, 80639, München-Nymphenburg
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej
Department of Rheumatology and Internal Diseases, Ul Gen Augusta Emila Fieldorfa 2, 54-049, Wroclaw
Nova Reuma Domyslawska i Rusilowicz Sp. Partnerska
Lekarza Reumatologa i Fizjoterapeuty, Ul. Prowiantowa 15, 15-707, Bialystok
Ośrodek Badań Klinicznych Wczesnych Faz
Uniwersyteckiego Centrum Klinicznego w Gdańsku, ul. Smoluchowskiego 17, 80-214, Gdańsk
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2022-07-26 | 2025-04-25 | 2022-08-26 | ||
| Poland | 2023-01-19 | 2025-04-25 | 2023-03-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517406-29 | 7.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder | none |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Placeholder | none |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DEU | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_POL_pl | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Placeholder | none |
| Subject information and informed consent form (for publication) | L2_Other subject information materials_Placeholder | none |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prednisolone-Jenapharm | None |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Germany | Acceptable 2024-10-30
|
2024-11-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-14 | Germany | Acceptable 2024-10-30
|
2025-02-14 |