OsteoarthritisPhase 1NCT03311009
A Study With GLPG1972 in Osteoarthritis Subjects
A Phase 1 study testing GLPG1972 cohort 1, GLPG1972 cohort 2 and GLPG1972 cohort 3 in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- GLPG1972 cohort 1, GLPG1972 cohort 2 and GLPG1972 cohort 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 25 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of non-childbearing potential, 50-75 years of age on the date of signing the Informed Consent Form (ICF), inclusive extremes.
- Diagnosis of OA (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence.
- A body mass index (BMI) between 18.0 and 34.9 kg/m2, inclusive extremes.
- Judged to be in age-appropriate good health by the investigator based upon the results of a medical history, physical examination, vital signs and 12-lead ECG, and fasting clinical laboratory profile.
- Subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment.
Who cannot join
- Administration of intraarticular glucocorticoid injections or hyaluronan injections in the last 3 months prior to study screening.
- Subjects who underwent or are on a waiting list for total hip or knee replacement and any other surgery planned during the study (up to Day 50).
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Positive serology for HBsAg or HCV antibody or history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition.
- Clinically significant serious, per investigator's discretion, and/or unstable illness in the 3 months before screening
Show all 13Show fewer
- Renal function with an estimated creatinine clearance < 60 mL/min based on the Cockcroft-Gault formula. Retesting is allowed once (see Section 5.2).
- Use of verapamil, diltiazem, amitriptyline, warfarin, acenocoumarol, phenobarbital and phenytoin, within 4 weeks before first study drug administration
- Consumption of herbal medications that are strong inhibitors and/or inducers of CYPs (e.g., St. John's Wort) and grapefruit/grapefruit products, Seville oranges, or any poppy seed, within 7 days prior to the first study drug administration.
- History of solid organ or hematopoietic cell transplantation.
- History of malignancy within the past 5 years.
- Clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction (e.g., QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females, or a known long QT syndrome).
- Significant blood loss (including blood donation [> 450 mL]), or transfusion of any blood product within 12 weeks prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Doses of GLPG1972 for 4 Weeks in Subjects With Osteoarthritis
This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.
- Conditions
- Osteoarthritis
- Being tested
- GLPG1972 cohort 1, GLPG1972 cohort 2, GLPG1972 cohort 3, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1972 cohort 1Drug
GLPG1972 dose 1 provided as oral tablets q.d.
GLPG1972 cohort 2Drug
GLPG1972 dose 2 provided as oral tablets q.d.
GLPG1972 cohort 3Drug
GLPG1972 dose 3 provided as oral tablets q.d.
PlaceboDrug
Matching placebo provided as oral tablets q.d.
| Study group | Role | What they receive |
|---|---|---|
| GLPG1972 | Experimental | Not described Receives: Drug: GLPG1972 cohort 1; Drug: GLPG1972 cohort 2; Drug: GLPG1972 cohort 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between GLPG1972 treated subjects and placebo subjects in the number of Adverse Events
To assess safety and tolerability of GLPG1972 in OA patients
Measured: From screening until the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal vital signs
To assess safety and tolerability of GLPG1972 in OA patients
Measured: From screening until the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal clinical laboratory evaluations
To assess safety and tolerability of GLPG1972 in OA patients
Measured: Screening, Days -1, 2, 4, 8, 9, 15, 22, 29, 43 and the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal physical examination
To assess safety and tolerability of GLPG1972 in OA patients
Measured: Screening, days -1, 1, 2, 8, 15, 22, 29, 43 and the final follow up visit (day 50
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal ECG
To assess safety and tolerability of GLPG1972 in OA patients
Measured: Screening, days 1, 2, 3, 4, 8, 15, 22, 29, 43 and the final follow up visit (day 50)
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal Holter assessment
To assess safety and tolerability of GLPG1972 in OA patients
Measured: Day -1 to days 1 and Day 10 to day 11
The maximum observed plasma concentration of GLPG1972 (Cmax)
To assess PK of GLPG1972 in OA patients
Measured: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The time (tmax) to reach Cmax of GLPG1972
To assess PK of GLPG1972 in OA patients
Measured: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The plasma concentration of GLPG1972 24 after the last dose
To assess PK of GLPG1972 in OA patients
Measured: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
The area under the plasma concentration time curve from time 0 until the last quantifieble dose
To assess PK of GLPG1972 in OA patients
Measured: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
Secondary outcomes (1)
Percentage reduction of neo-epitope ARGS vs baseline
To assess PD of GLPE1972 in OA patients
Measured: Days 1, 3, 6, 8, 10, 15, 22, 29, 43 and the final follow up visit (day 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start15 May 2017
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Fieuw, MD, MSc, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311009
- Sponsor's protocol ID
- GLPG1972-CL-104
- Status last verified
- Nov 2017
- First submitted
- 11 Oct 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
PubMed 40826764
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Doses of GLPG1972 for 4 Weeks in Subjects With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03311009
- Acronym / sponsor ID
- GLPG1972-CL-104
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG1972 | Experimental | Drug: GLPG1972 cohort 1, Drug: GLPG1972 cohort 2, Drug: GLPG1972 cohort 3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects of non-childbearing potential, 50-75 years of age on the date of signing the Informed Consent Form (ICF), inclusive extremes.
- Diagnosis of OA (knee and/or hip) made by their physician based on symptoms, clinical signs and documented historical imaging evidence.
- A body mass index (BMI) between 18.0 and 34.9 kg/m2, inclusive extremes.
- Judged to be in age-appropriate good health by the investigator based upon the results of a medical history, physical examination, vital signs and 12-lead ECG, and fasting clinical laboratory profile.
- Subjects with a stable chronic illness at least 3 months will be accepted subject to the investigator's judgment.
Key exclusion criteria (13 listed)
- Administration of intraarticular glucocorticoid injections or hyaluronan injections in the last 3 months prior to study screening.
- Subjects who underwent or are on a waiting list for total hip or knee replacement and any other surgery planned during the study (up to Day 50).
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Positive serology for HBsAg or HCV antibody or history of hepatitis from any cause with the exception of hepatitis A.
- History of or a current immunosuppressive condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG1972 cohort 1GLPG1972 dose 1 provided as oral tablets q.d. | Drug | GLPG1972 |
| GLPG1972 cohort 2GLPG1972 dose 2 provided as oral tablets q.d. | Drug | GLPG1972 |
| GLPG1972 cohort 3GLPG1972 dose 3 provided as oral tablets q.d. | Drug | GLPG1972 |
| PlaceboMatching placebo provided as oral tablets q.d. | Drug | Placebo |
Primary outcome
Difference between GLPG1972 treated subjects and placebo subjects in the number of Adverse Events
Time frame: From screening until the final follow up visit (day 50)
To assess safety and tolerability of GLPG1972 in OA patients
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal vital signs
Time frame: From screening until the final follow up visit (day 50)
To assess safety and tolerability of GLPG1972 in OA patients
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal clinical laboratory evaluations
Time frame: Screening, Days -1, 2, 4, 8, 9, 15, 22, 29, 43 and the final follow up visit (day 50)
To assess safety and tolerability of GLPG1972 in OA patients
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal physical examination
Time frame: Screening, days -1, 1, 2, 8, 15, 22, 29, 43 and the final follow up visit (day 50
To assess safety and tolerability of GLPG1972 in OA patients
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal ECG
Time frame: Screening, days 1, 2, 3, 4, 8, 15, 22, 29, 43 and the final follow up visit (day 50)
To assess safety and tolerability of GLPG1972 in OA patients
Difference in the number of GLPG1972 treated subjects and placebo subjects with abnormal Holter assessment
Time frame: Day -1 to days 1 and Day 10 to day 11
To assess safety and tolerability of GLPG1972 in OA patients
The maximum observed plasma concentration of GLPG1972 (Cmax)
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
To assess PK of GLPG1972 in OA patients
The time (tmax) to reach Cmax of GLPG1972
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
To assess PK of GLPG1972 in OA patients
The plasma concentration of GLPG1972 24 after the last dose
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
To assess PK of GLPG1972 in OA patients
The area under the plasma concentration time curve from time 0 until the last quantifieble dose
Time frame: Days 1, 2, 3, 4, 6, 8, 10, 15, 16, 22, 29 and 43
To assess PK of GLPG1972 in OA patients
1 secondary outcome
Percentage reduction of neo-epitope ARGS vs baseline
Time frame: Days 1, 3, 6, 8, 10, 15, 22, 29, 43 and the final follow up visit (day 50)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Derived from this study: PubMed 40826764Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Fieuw, MD, MSc study director
Lakefront Biotherapeutics NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG1972 cohort 1, GLPG1972 cohort 2 and GLPG1972 cohort 3 in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between GLPG1972 treated subjects and placebo subjects in the number of Adverse Events (time frame: From screening until the final follow up visit (day 50)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.