CHRONOS - A study to learn about the effects and safety of ODM-111 in participants with long-lasting pain due to osteoarthritis of the knee.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Orion Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

completed 28 Oct 2024

Decision date (initial)

2024-10-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy

To evaluate the efficacy of ODM-111 in the treatment of chronic pain due to knee osteoarthritis.

Conditions and MedDRA coding

Chronic Pain due to Ostheoarthritis of the knee

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Clinical data sharing, including IPD sharing, for this trial will follow the Clinical Data Sharing Policy of the Sponsor (Orion Corporation). Further information can be found at https://www.orion.fi/en/sustainability/ethical-business/research-development-ethics-policy/sharing-clinical-data/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Signed informed consent (IC) for participation in the trial.
2. Males and females ≥ 40 years of age at screening visit.
3. BMI 18-40 kg/m2 at screening visit.
4. A diagnosis of OA according to the American College of Rheumatology (ACR) criteria and Kellgren-Lawrence (KL) grade 2-4 in the index knee joint at the screening visit.
5. OA of knee(s) is the primary painful condition and pain in the index knee joint (more symptomatic knee, appointed by the participant in case both sides equally affected) must have been present for >6 months at screening visit.
6. OA pain in the index knee joint as follows: o WOMAC pain subscale (LK3.1) of [blinded information] out of 10 points at screening and baseline visits, and o weekly average of daily pain intensity [blinded information] on the 11-point NRS at baseline, based on daily assessments over at least 5 of the past 7 consecutive days preceding the baseline visit.
7. ACR Functional class I-III.
8. Female participants with fertile male partners, and male participants with female partners of childbearing potential, must adhere to a highly effective form of contraception (e.g. combined or progestogen only hormonal contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system), if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration, and for males from Day 1 until 3 months after the EOS visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male participants, sperm donation is not allowed until 3 months after the EOS visit.

Exclusion criteria 10

1. A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or to communicate well with the investigator. Incapacitated persons will not be enrolled in the trial.
2. Females who are pregnant or lactating at screening, or planning to become pregnant within 1 month from the last dose of study treatment.
3. Conditions that may involve the index joint and could confound or interfere with efficacy assessments, such as history of reactive, rheumatoid or psoriatic arthritis, ankylosing spondylitis, sarcoidosis, amyloidosis, fibromyalgia, or active infection of the index joint.
4. History of joint replacement surgery in the index joint.
5. History of surgery of the index joint (arthroscopic or open) within the previous year or planned during the trial.
6. Intra-articular injections of the index joint within 3 months for corticosteroid or saline and within 6 months prior to the screening visit for other injections, or planned during the trial.
7. Use of analgesic treatment during the trial (from at least 10 days before the baseline visit until the last treatment visit), excluding the following: a. Paracetamol as rescue analgesia, up to 3 g daily, not within 24 hours prior to any treatment period visit. b. Acetylsalicylic acid for cardiovascular reasons, stable dosing up to 325 mg daily.
8. A diagnosis of long COVID (including self-diagnosis by participant)
9. Recent history of cancer (<5 years) except basal cell carcinoma or squamous cell carcinoma of the skin.
10. Known hypersensitivity to the active substance or to any of the excipients of the study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint is the change from baseline to week 6 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale

Investigational products

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

Test 2

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Orion Corporation

Sponsor organisation

Orion Corporation

Address

P. O. Box 65

City

Espoo

Postcode

02101

Country

Finland

Scientific contact point

Organisation

Orion Corporation

Contact name

Clinical Study Director

Public contact point

Organisation

Orion Corporation

Contact name

Clinical Study Director

Third parties 4

Locations

5 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 133 files

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

Application history

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