SK-5307 Phase II/III study

JRCT ID: jRCT2031230524

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acromegaly and pituitary gigantism
• Date of first enrollment: 12/03/2024
• Target sample size: 33
• Study type: Interventional

Intervention(s)

Treatment Period I (12 weeks)
SK-5307 (any of Dose 1, Dose 2, or Dose 3) is orally administered once a day.
Treatment Period II (40 weeks)
SK-5307 is orally administered once a day to the subjects who have completed Treatment Period I. The dose is adjusted within the range of Dose 1, Dose 2, or Dose 3.

Outcome(s)

Primary Outcome

Treatment Period I
Change from baseline in serum IGF-1 concentration at the end of Treatment Period I
Treatment Period II.
Percentage of the subjects achieving serum IGF-1 concentrations within the reference ranges for age and gender at the end of Treatment Period II.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects who were diagnosed with acromegaly or pituitary gigantism and have undergone pituitary surgery at least once, refused to undergo pituitary surgery or with contraindications to pituitary surgery.
Subjects whose serum IGF-1 concentration is 1.3 times higher than the upper limit of normal (ULN) for age and gender at the screening test.
Subjects who have never used existing medications to treat acromegaly or pituitary gigantism.
Subjects on existing monotherapy to treat acromegaly or pituitary gigantism without any changes in the dosage and administration for 12 weeks prior to providing written informed consent.
Subjects who have participated in any previous clinical study of SK-5307 and received SK-5307 (excluding placebo of SK-5307).
Subjects deemed inappropriate by the investigator or subinvestigator.

Exclude criteria

Subjects with a history of ineffectiveness of or significant intolerance for existing medications.
Subjects deemed unsuitable for existing monotherapy.
Subjects who are receiving two or more medications to treat acromegaly or pituitary gigantism at the time of the informed consent.
Subjects who underwent pituitary radiation therapy within 3 years prior to the screening test.
Subjects who underwent pituitary surgery within 12 weeks prior to the screening test.
Subjects with a high risk of pituitary tumor.
Subjects with hypersensitivity or a history of hypersensitivity to somatostatin analogue.
Subjects with symptomatic cholelithiasis.

Related Information

• Primary Sponsor: Kenji Asano