A Phase 2a Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)

2026-525817-29-00 Protocol SUN-627-MS201 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol SUN-627-MS201

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 30
Countries 1
Sites 1

Multiple Sclerosis; Primary Progressive Multiple Sclerosis; non-active Secondary Progressive Multiple Sclerosis

To assess safety and tolerability of SUN-627

Key facts

Sponsor
Sundance Biosciences Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Immune System Diseases [C20]
Decision date (initial)
2026-06-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Sundance Biosciences, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacodynamic

To assess safety and tolerability of SUN-627

Secondary objectives 3

  1. To characterize the PK of SUN-627
  2. To evaluate cerebrospinal fluid (CSF) biomarkers of SPMS/PPMS disease progression
  3. To evaluate imaging measures of inflammation in the CNS

Conditions and MedDRA coding

Multiple Sclerosis; Primary Progressive Multiple Sclerosis; non-active Secondary Progressive Multiple Sclerosis

VersionLevelCodeTermSystem organ class
20.1 PT 10028245 Multiple sclerosis 100000004852

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Phase 2a Study of SUN-627 in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)
This is a Phase 2a, single-center study of a single dose level of orally administered SUN-627 to evaluate its safety, tolerability, PK, PD, and impact on measures of neuroinflammation in the CNS of participants with non-active SPMS/PPMS.
 2 None Experimental: SUN-627: Orally-administered SUN-627

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Aged 18-70, inclusive
  2. Diagnosis of PPMS or non-active SPMS
  3. No MS relapses in the past 2 years
  4. Evidence that MS has continued to get worse over time
  5. A level of disability that fits the study requirements
  6. Additional inclusion criteria are outlined in the full study protocol.

Exclusion criteria 6

  1. Use of certain medications or treatments before the study, or need for these treatments during the study
  2. Current participation in another research study
  3. Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk
  4. Certain serious or unstable medical conditions that could make the study unsafe
  5. Active infection, recent infection, or a history of repeated infections
  6. Additional exclusion criteria are outlined in the full study protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Time Frame: From enrollment to the end of study at 16 weeks

Secondary endpoints 1

  1. Markers of disease in blood and brain fluid as well as imaging to measure inflammation Time Frame: from enrollment to the end of treatment at 12 weeks

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

SUN-627

PRD13834380 · Product

Active substance
SUN-627
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
10080 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
SUNDANCE BIOSCIENCES INC.
Paediatric formulation
No
Orphan designation
No

SUN-627

PRD13834378 · Product

Active substance
SUN-627
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
10080 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
SUNDANCE BIOSCIENCES INC.
Paediatric formulation
No
Orphan designation
No

SUN-627

PRD13834379 · Product

Active substance
SUN-627
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
10080 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
SUNDANCE BIOSCIENCES INC.
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sundance Biosciences Inc.

Sponsor organisation
Sundance Biosciences Inc.
Address
343 Oyster Point Boulevard Ste 120
City
South San Francisco
Postcode
94080-1913
Country
United States

Scientific contact point

Organisation
Sundance Biosciences Inc.
Contact name
Chetan Gandhy, MD

Public contact point

Organisation
Sundance Biosciences Inc.
Contact name
Tom DeMelfi, MS

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Finland Authorised, recruitment pending 30 1
Rest of world — 0 —

Investigational sites

Finland

1 site · Authorised, recruitment pending
Turku University Hospital
Department of Neurology, Kiinamyllynkatu 4-8, 20520, Turku

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2026-525817-29-00_Redacted 2
Protocol (for publication) D4_Patient facing documents_C-SSRS_Screening_FI 14/01/09
Protocol (for publication) D4_Patient facing documents_C-SSRS_Screening_SE 14/01/09
Protocol (for publication) D4_Patient facing documents_C-SSRS_SLV_FI 14/01/09
Protocol (for publication) D4_Patient facing documents_C-SSRS_SLV_SE 14/01/09
Protocol (for publication) D4_Patient facing documents_EDSS_Definitions 04/10.2
Protocol (for publication) D4_Patient facing documents_EDSS_Scoring sheet 04/10.2
Protocol (for publication) D4_Patient facing documents_MFIS-5_FI N/A
Protocol (for publication) D4_Patient facing documents_MFIS-5_SE N/A
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_FI v1.0
Recruitment arrangements (for publication) K2_Recruitment material_leaflet_FI 1
Recruitment arrangements (for publication) K2_Recruitment material_social media_FI 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main Study_FI_Redacted v2.1
Subject information and informed consent form (for publication) L2_Other subject information material_Optional Future Research_FI_Redacted 2
Subject information and informed consent form (for publication) L2_Other subject information material_Pregnant Partner_FI_Redacted 2
Synopsis of the protocol (for publication) D2_Protocol synopsis_2026-525817-29-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-04-11 Finland Acceptable
2026-06-02
 2026-06-05
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-06-18 Finland Acceptable
2026-06-02
 2026-06-18