臨床研究等提出・公開システム

SK-5307 Phase II/III study (double-blind, parallel-group comparative study and open-label, uncontrolled extension study in subjects with acromegaly and pituitary gigantism)

SK-5307 Phase II/III study

Kazuo Kuyama

Sanwa Kagaku Kenkyusho Co.,Ltd.

Heiwa Fudosan Sakuradori Bldg. (Reception 6F) , 1-3-7, Nishiki, Naka-ku, Nagoya City, Aichi Prefecture

clinicaltrials@ml.skk-net.com

Kazuo Kuyama

Sanwa Kagaku Kenkyusho Co.,Ltd.

Heiwa Fudosan Sakuradori Bldg. (Reception 6F) , 1-3-7, Nishiki, Naka-ku, Nagoya City, Aichi Prefecture

+81-52-951-8130

clinicaltrials@ml.skk-net.com

Complete

Dec. 15, 2023

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

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.

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.

Both

acromegaly and pituitary gigantism

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.

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.

+81-3-5213-0028

Dec. 18, 2023

No

none