Could you be eligible for a clinical trial in acromegaly?

Are you or your loved ones affected by acromegaly?

Are you eligible?

Could you be eligible for a clinical trial in acromegaly?

Are you or your loved ones affected by acromegaly?

Are you eligible?

Are you interested in taking part in the development of a potential new treatment for acromegaly?

The biopharmaceutical company Camurus is developing a new investigational formulation of the medicine octreotide, which has been a standard treatment for acromegaly for over 30 years.

This new investigational formulation of octreotide, currently called CAM2029, will be given once monthly as an injection under the skin (subcutaneous). To date, CAM2029 has been tested in healthy volunteers and patients in 4 early stage clinical trials.

CAM2029 is currently being investigated in patients with acromegaly in two large-scale, global, phase 3 clinical trials: HS-18-633 and HS-19-647.

Clinical trial HS-18-633

Double blindA double-blind trial is one in which neither the patients nor the medical staff treating them know whether the patient is receiving the active medicine or treatment that is under investigation or a placebo. This helps to prevent bias when the results of the trial are evaluated.
Placebo controlledA placebo-controlled trial is one in which, in addition to a group of patients that receive the medicine or treatment that is being investigated, a separate placebo or control group receives a placebo treatment that does not contain the active ingredient and is specifically designed to have no real effect. A placebo is used in blinded trials.

Patients currently being treated with octreotide or lanreotide

6 monthly doses of CAM2029 or placebo

Potential for self-injection under supervision of trial personnel

Patients with well controlled IGF-1 levels and who have not undergone radiotherapy

The effect of CAM2029 to maintain control of the disease following the patient’s previous treatment is investigated

Clinical trial HS-18-633

Are you eligible for this clinical trial?
You may be eligible for the HS-18-633 clinical trial if you have been on a stable dose of octreotide or lanreotide for at least 3 months and your levels of insulin-like growth factor 1 (IGF-1) are well controlled.

See the ‘Are you eligible section?’ for more details.

Trial summary
The aim of the HS-18-633 clinical trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly who are currently being treated with octreotide or lanreotide.

CAM2029 will be given once monthly as an injection under the skin (subcutaneous injection). Patients in this trial will have the possibility to perform the injection themselves under supervision of trial personnel. Alternatively, the patient’s partner can also perform the injection after training under supervision of trial personnel. A total of 6 monthly doses will be given.

The effects of CAM2029 will be followed. This will include the effects of the treatment on the patient’s acromegaly, their well-being and quality of life.

After 6 months, patients will be asked if they would like to continue taking CAM2029 for another 6 months in a follow-up trial, called HS-19-647.

Read more about the HS-18-633 trial

Clinical trial HS-19-647

Open-labelAn open-label trial is one in which the patients and the medical staff treating them know which treatment the patient is receiving.

Patients currently or previously treated with octreotide or lanreotide OR patients treated in clinical trial HS-18-633

13 monthly doses of CAM2029
(7 monthly doses for patients from clinical trial HS-18-633)

Potential for self-injection under supervision of trial personnel and, after being trained, at home without supervision.

Patients do not need to have well controlled IGF-1 levels and are allowed to have undergone radiotherapy

The effect of CAM2029 to maintain control of the disease following the patient’s previous treatment or when the patient’s previous treatment is not fully controlling their disease symptoms is investigated

Clinical trial HS-19-647

Are you eligible for this clinical trial?
You may be eligible for the HS-19-647 clinical trial if you have been on a stable dose of octreotide or lanreotide for at least 3 months. You may also be eligible if you have previously received radiotherapy (irradiation) treatment or you have received treatment with CAM2029 in clinical trial HS-18-633. Your levels of insulin-like growth factor 1 (IGF-1) do not necessarily have to be well controlled.

See the ‘Are you eligible section?’ for more details.

Trial summary
The aim of the HS-19-647 clinical trial is to assess the safety and efficacy of CAM2029 in two groups of patients:

  • Group 1. Patients with acromegaly who are currently being treated with octreotide or lanreotide.
  • Group 2. Patients who previously received treatment with CAM2029 or placebo for 6 months in the HS-18-633 trial.

CAM2029 will be given once monthly as an injection in the fatty tissue under the skin (subcutaneous injection). Patients in this trial will have the possibility to perform the injection themselves under supervision by trial personnel and also at home for 4 of the doses after being trained. Alternatively, the patient’s partner can also perform the injection. A total of 13 monthly doses will be given.

The effects of CAM2029 will be studied. This will include the effects of the treatment on the patient’s acromegaly, their well-being and quality of life.

Read more about the HS-19-647 trial

About Camurus

Camurus is a Swedish, science-led, biopharmaceutical company that is committed to developing and commercialising long-acting medicines for the treatment of severe and chronic conditions.

Camurus develops new treatments based on our proprietary FluidCrystal® drug delivery technologies and known active ingredients.

Camurus’ clinical pipeline includes products for the treatment of chronic serious diseases, such as acromegaly and neuroendocrine tumors, which are developed in-house and in collaboration with international pharmaceutical companies.

Links to other sections: