Chronic Osteoarthritis PainPhase 1NCT06810245
Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain
A Phase 1 study testing PIPE-791 in people with Chronic Osteoarthritis Pain and Chronic Low Back Pain, run by Contineum Therapeutics at 5 sites in United States.
Trial summary
The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Osteoarthritis Pain, Chronic Low Back Pain
- What is being tested?
- PIPE-791
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Feb 2025to 20 Jan 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 70 years of age, inclusive, at the first Screening visit.
- Only one of the following chronic pain diagnoses at least 6 months prior to Screening:
- Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy)
- Plain radiographs of the knee or lumbar spine consistent with diagnosis within 9 months prior to or during Screening.
- History of related daily pain for at least 6 months prior to Screening.
- Have a body mass index <40 (inclusive) at Screening.
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- Willing to maintain a consistent regimen of any ongoing (stable format and frequency for the duration of study participation) non-pharmacologic pain-relieving therapies.
- Willing to discontinue medications taken for chronic pain conditions and usage of transcutaneous electrical nerve stimulation for the duration of the study.
- Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 90 days after last study drug administration.
- Subjects taking systemic hormone-replacement therapy must be on a stable dose and regimen for at least 1 month prior to Screening.
- General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying chronic pain condition, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.
- Ability to use an eDiary to record daily pain scores.
Who cannot join
- History of refractory chronic pain after multiple failed treatments as determined by the Investigator (e.g., no response to all of the following: surgery and/or nerve blocks, a regimen of at least two non-opioid pharmacotherapies, and physical rehabilitation, and weak opioids).
- Concurrent diagnosis of fibromyalgia or evidence of chronic widespread pain, or other pain that may interfere with the assessment of CLBP or COAP.
- Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening.
- Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest, e.g., an ablation procedure.
- Received capsaicin treatment (e.g., Qutenza) within the past 3 months prior to screening.
- Have surgery planned during the study for any reason, related or not, to the disease state under evaluation.
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- Are non-ambulatory (use of assistive devices is allowed).
- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
- Diagnosed with OA during childhood or adolescence, including post-traumatic OA or OA due to genetic (e.g., hip dysplasia) or congenital (e.g., metabolic disorders) conditions.
- History of or clinical signs or symptoms of active joint infection, crystal disease of the knee, or a history of arthritis due to crystals (e.g., gout, pseudo gout).
- History of prior lumbar or thoracic spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Altoona Center of Clinical Research
Duncansville, Pennsylvania, 16635
Drug Trials America
Hartsdale, New York, 10530
Drug Studies America
Marietta, Georgia, 30060
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 as Treatment in Subjects With Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)
The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP.
Subjects will:
- Complete a washout period to stop their current pain medications.
- Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks.
- Record pain levels and track dosing in a daily e-diary.
- Visit the clinic for checkups and lab tests throughout the study.
- Complete phone assessments during the treatment periods.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, 2-period crossover study designed to evaluate the safety and tolerability of PIPE-791 in approximately 20 adults with COAP and 20 adults with CLBP (with or without painful lumbosacral radiculopathy). Subjects will be randomized to receive either PIPE-791 or placebo daily for 4 weeks, followed by a crossover to the alternate treatment assignment for an additional 4 weeks.
A washout period of all chronic pain medications is required prior to randomization. Rescue medications, including acetaminophen and naproxen, will be permitted during the study.
Subjects will complete regular clinic visits for safety assessments, laboratory testing, and physical evaluations. Daily pain scores and dosing information will be reported by subjects using an electronic diary (e-diary).
All subjects who complete dosing will have a post-treatment safety follow-up/end of study (EOS) phone visit approximately 28 days after the last dose of study drug. Subjects who prematurely discontinue dosing and all assessments from the study will have an early termination (ET) visit as soon as possible on or after their last dose of study drug.
The total duration of participation, including screening, treatment, and follow-up, is approximately 16 weeks.
- Conditions
- Chronic Osteoarthritis Pain, Chronic Low Back Pain
- Being tested
- PIPE-791, Placebo
- Keywords
- chronic pain, pain, low back pain, osteoarthritis pain, osteoarthritis, pain management, neuropathic pain, CLBP, COAP, OA
- Medical subject headings
- Chronic Pain, Pain, Low Back Pain, Osteoarthritis, Agnosia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPE-791Drug
PIPE-791 tablet, taken once daily for 4 weeks
PlaceboDrug
Placebo tablet, taken once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active followed by Placebo | Experimental | Not described Receives: Drug: PIPE-791; Drug: Placebo |
| Placebo followed by Active | Experimental | Not described Receives: Drug: PIPE-791; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Treatment-emergent adverse events (TEAEs)
The number of subjects with TEAEs will be summarized in each treatment arm and compared within each treatment period.
Measured: For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start4 Feb 2025
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
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 Chronic Osteoarthritis PainStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contineum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810245
- Sponsor's protocol ID
- CTX-791-103
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen A, Baccei C, Baccei J, Broadhead A, Lorrain KI, Poon MM, Roppe J, Schrader TO, Stebbins KJ, Valdez L, Xiong Y, Lorrain DS. Discovery of PIPE-791, A Potent and Brain-Penetrant Lysophosphatidic Acid Receptor 1 Antagonist with Slow Tight Binding Characteristics for the Treatment of Neuroinflammatory Disorders. J Med Chem. 2026 Jul 9;69(13):15888-15927. doi: 10.1021/acs.jmedchem.6c01049. Epub 2026 Jun 29.
PubMed 42370792
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Crossover Multicenter Study to Explore the Safety and Efficacy of Oral PIPE-791 as Treatment in Subjects With Chronic Osteoarthritis Pain (COAP) or Chronic Low Back Pain (CLBP)
- ClinicalTrials.gov ID
- NCT06810245
- Acronym / sponsor ID
- CTX-791-103
- Conditions
- Chronic Osteoarthritis Pain, Chronic Low Back Pain
- Keywords
- chronic pain, pain, low back pain, osteoarthritis pain, osteoarthritis, pain management, neuropathic pain, CLBP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Contineum TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 5 Feb 2025 (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.
The primary goal of this clinical trial is to learn if PIPE-791 is safe and well-tolerated in adults with chronic osteoarthritis pain (COAP) or chronic low back pain (CLBP). The study will also explore whether PIPE-791 lowers pain in people with COAP or CLBP.
Subjects will:
- Complete a washout period to stop their current pain medications.
- Take a daily dose of PIPE-791 or placebo for 4 weeks, then reverse treatment assignment for another 4 weeks.
- Record pain levels and track dosing in a daily e-diary.
- Visit the clinic for checkups and lab tests throughout the study.
- Complete phone assessments during the treatment periods.
Detailed description
This is a double-blind, randomized, placebo-controlled, 2-period crossover study designed to evaluate the safety and tolerability of PIPE-791 in approximately 20 adults with COAP and 20 adults with CLBP (with or without painful lumbosacral radiculopathy). Subjects will be randomized to receive either PIPE-791 or placebo daily for 4 weeks, followed by a crossover to the alternate treatment assignment for an additional 4 weeks.
A washout period of all chronic pain medications is required prior to randomization. Rescue medications, including acetaminophen and naproxen, will be permitted during the study.
Subjects will complete regular clinic visits for safety assessments, laboratory testing, and physical evaluations. Daily pain scores and dosing information will be reported by subjects using an electronic diary (e-diary).
All subjects who complete dosing will have a post-treatment safety follow-up/end of study (EOS) phone visit approximately 28 days after the last dose of study drug. Subjects who prematurely discontinue dosing and all assessments from the study will have an early termination (ET) visit as soon as possible on or after their last dose of study drug.
The total duration of participation, including screening, treatment, and follow-up, is approximately 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active followed by Placebo | Experimental | Drug: PIPE-791, Drug: Placebo |
| Placebo followed by Active | Experimental | Drug: PIPE-791, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female 18 to 70 years of age, inclusive, at the first Screening visit.
- Only one of the following chronic pain diagnoses at least 6 months prior to Screening:
- Osteoarthritis of the knee OR low back pain (with or without painful lumbosacral radiculopathy)
- Plain radiographs of the knee or lumbar spine consistent with diagnosis within 9 months prior to or during Screening.
- History of related daily pain for at least 6 months prior to Screening.
Key exclusion criteria (11 listed)
- History of refractory chronic pain after multiple failed treatments as determined by the Investigator (e.g., no response to all of the following: surgery and/or nerve blocks, a regimen of at least two non-opioid pharmacotherapies, and physical rehabilitation, and weak opioids).
- Concurrent diagnosis of fibromyalgia or evidence of chronic widespread pain, or other pain that may interfere with the assessment of CLBP or COAP.
- Demonstrated noncompliance recording daily Numerical Rating Scale (NRS) scores during Screening.
- Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest, e.g., an ablation procedure.
- Received capsaicin treatment (e.g., Qutenza) within the past 3 months prior to screening.
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 |
|---|---|---|
| PIPE-791PIPE-791 tablet, taken once daily for 4 weeks | Drug | Active followed by Placebo, Placebo followed by Active |
| PlaceboPlacebo tablet, taken once daily for 4 weeks | Drug | Active followed by Placebo, Placebo followed by Active |
Primary outcome
Number of subjects with Treatment-emergent adverse events (TEAEs)
Time frame: For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).
The number of subjects with TEAEs will be summarized in each treatment arm and compared within each treatment period.
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 18 Mar 2026.
- Derived from this study: PubMed 42370792Chen A, Baccei C, Baccei J, Broadhead A, Lorrain KI, Poon MM, Roppe J, Schrader TO, Stebbins KJ, Valdez L, Xiong Y, Lorrain DS. Discovery of PIPE-791, A Potent and Brain-Penetrant Lysophosphatidic Acid Receptor 1 Antagonist with Slow Tight Binding Characteristics for the Treatment of Neuroinflammatory Disorders. J Med Chem. 2026 Jul 9;69(13):15888-15927. doi: 10.1021/acs.jmedchem.6c01049. Epub 2026 Jun 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIPE-791 in people with Chronic Osteoarthritis Pain and Chronic Low Back Pain, run by Contineum Therapeutics at 5 sites 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 12 inclusion and 11 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
Number of subjects with Treatment-emergent adverse events (TEAEs) (time frame: For Treatment Period 1, from Baseline (Day 1) to End of Treatment Period 1 (TP1; Day 29), for Treatment Period 2, from Baseline of Treatment Period 2 (TP2; Day 29) to End of TP2 (Day 57).). 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 NCT06810245, 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 18 Mar 2026.