Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly (TULIPIA)

Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients

The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in patients with acromegaly after 6 months of treatment.

Study Overview

• Status: Terminated
• Conditions: Acromegaly
• Intervention / Treatment: Drug: BIM 23A760

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, B-4000
    • Centre Hospitalier Universitaire de Liège
• Brazil
  • Rio de Janeiro, Brazil, 21941-913
    • Hospital Universitario Clementino Fraga Filho
  • Sao Paulo, Brazil, 05403-0000
    • Hospital das Clínicas de São Paulo
• Czechia
  • Olomouc, Czechia, 775 20
    • University Hospital Olomouc, Clinic of Internal Medicine
  • Praha, Czechia, 128 08
    • General University Hospital, Clinic of Internal Medicine,
• France
  • Le Kremlin Bicêtre, France, 94275 Cedex
    • Hôpital Bicêtre
  • Marseille, France, 13385 cedex 05
    • Hôpital de la Timone
• Latvia
  • Riga, Latvia, LV 1002
    • P. Stradins Clinical University Hospital
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Kaunas Medical University Hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital "Santariskiu Klinikos"
• Mexico
  • Mexico City, Mexico, DF
    • UIM Endocrinología Experimental, Hospital de Especialidades
  • México City, Mexico, 14269 México
    • Insituto Nacional de Neurologia y Neurocirugia
• Netherlands
  • Rotterdam, Netherlands, 3000 CA
    • Department of Endocrinology, Erasmus MC
• Poland
  • Rybnik, Poland, 44-200
    • Voivodeship Specialistic Hospital No 3
• Romania
  • Bucharest, Romania, 011863
    • "C.I. Parhon" National Institute of Endocrinology
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital
• Ukraine
  • Kharkiv, Ukraine, 61002
    • Academy of Medical Science of Ukraine, Department of Clinical Endocrinology
  • Kyiv, Ukraine, 04050
    • Administration of Medical Services and Rehabilitation of "ARTEM"
  • Vinnitsa, Ukraine, 21010
    • National Medical University n.a. M.I.Pirogov
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Pituitary Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital / Neuroendocrine Unit
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon University, Dept. of Endocrinology and Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• IGF-1 ≥1.3 x upper limit normal (ULN)
• Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
• Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

Exclusion Criteria:

• The patient has received long acting somatostatin analogues within 6 months of study entry
• The patient has undergone radiotherapy at any time prior to study entry
• The time between pituitary surgery (if any) and study entry is less than 6 weeks
• The patient suffers from macroadenoma with visual field defects due to chiasmatic compression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIM 23A760 1 mg	Drug: BIM 23A760; Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 2 mg	Drug: BIM 23A760; Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 4 mg	Drug: BIM 23A760; Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.
Experimental: BIM 23A760 6 mg	Drug: BIM 23A760; Subcutaneous injections of BIM23A760 once a week. Until progression or unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1	At Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1		At Month 3
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1		At Month 1
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6	Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline	0-3 hr on Baseline (Day 1) and Months 1, 3 and 6
Changes in IGF-1		Baseline (Day 1) and Month 6
Percentage Change in Ring Finger Circumference	Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.	Baseline (Day 1) and Month 6
Number of Subjects Reported Adverse Events During the Study	For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.	Up to Visit 10 (An average of 6.5 Months)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: 2-55-52060-003; 2009-010787-42 (EudraCT Number)