A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)

Sponsor

Sparrow Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05436652

Collaborator

(none)

Enrollment

Locations

Arms

17.2

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR.

Condition or Disease	Intervention/Treatment	Phase
Polymyalgia Rheumatica	Drug: SPI-62 Drug: SPI-62 matched placebo Drug: Prednisolone 10mg Drug: Additional prednisolone Drug: Additional prednisolone matched placebo	Phase 2

Detailed Description

This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR. Up to 4 cohorts of 12 subjects could be recruited (12 to 48 subjects). Each subject 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 subjects 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 4, the dose of prednisolone co-administered with SPI-62 could be adjusted.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Participant)

Masking Description:

Drug and Placebo are masked and assigned via Interactive Response Technology (IRT)

Primary Purpose:

Treatment

Official Title:

A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)

Anticipated Study Start Date :

Jul 22, 2022

Anticipated Primary Completion Date :

Sep 29, 2023

Anticipated Study Completion Date :

Dec 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPI-62 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.	Drug: SPI-62 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor Drug: SPI-62 matched placebo Inactive tablets identical in appearance to SPI-62 tablets Drug: Prednisolone 10mg Standard of care prednisolone
Experimental: SPI-62 + additional prednisolone 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.	Drug: SPI-62 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor Drug: SPI-62 matched placebo Inactive tablets identical in appearance to SPI-62 tablets Drug: Prednisolone 10mg Standard of care prednisolone Drug: Additional prednisolone Over encapsulated prednisolone Drug: Additional prednisolone matched placebo Inactive capsules identical in appearance to over encapsulated prednisolone

Arm

Intervention/Treatment

Experimental: SPI-62

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.

Drug: SPI-62

11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

Drug: SPI-62 matched placebo

Inactive tablets identical in appearance to SPI-62 tablets

Drug: Prednisolone 10mg

Standard of care prednisolone

Experimental: SPI-62 + additional prednisolone

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.

Drug: SPI-62

11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

Drug: SPI-62 matched placebo

Inactive tablets identical in appearance to SPI-62 tablets

Drug: Prednisolone 10mg

Standard of care prednisolone

Drug: Additional prednisolone

Over encapsulated prednisolone

Drug: Additional prednisolone matched placebo

Inactive capsules identical in appearance to over encapsulated prednisolone

Outcome Measures

Primary Outcome Measures

Erythrocyte sedimentation rate [Baseline to Day 28]
C-reactive protein [Baseline to Day 28]
Plasma fibrinogen [Baseline to Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie	Berlin	Germany
2	Internistische Praxisgemeinschaft Rheumatologie . Nephrologie	Erlangen	Germany
3	Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin	Hamburg	Germany
4	Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität	Herne	Germany
5	Unikliniken Köln	Köln	Germany
6	Prof. Dr. med. Herbert Kellner	Munich	Germany