OsteonecrosisPhase 2LLP2A-AleNCT07471880

A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head

A Phase 2 study testing RAB001 high dose, RAB001 medium dose and RAB001 low dose in people with Osteonecrosis and Osteonecrosis of the Femoral Head, run by ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Osteonecrosis, Osteonecrosis of the Femoral Head
What is being tested?: RAB001 high dose, RAB001 medium dose and RAB001 low dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 1 siteChina
Study dates: 24 Dec 2024to 28 Feb 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years ≤ age ≤ 69 years, gender not limited;
Patients with glucocorticoid-induced osteonecrosis of the femoral head (ONFH) according to the 2019 edition of the "Guidelines for clinical diagnosis and treatment of osteonecrosis of the femoral head in adults", with an ARCO stage of II, and confirmed by CT and MRI examinations to have no femoral head collapse, and the time from first glucocorticoid use to the screening period must exceed 30 days;
The participant has no plans for hip surgery on the target side within the next 54 weeks;
Participants with unilateral or bilateral ONFH are not restricted. For unilateral involvement, the affected side (as the target side) must have no femoral head collapse confirmed by hip CT examination. For bilateral involvement, hip CT examination must confirm that at least one side has no collapse (the non-collapsed side is the target side; if both sides are necrotic and neither has collapsed, the side with more severe necrosis is the target side. If the contralateral side of the target side meets the criteria for study-defined osteonecrosis, all study information must be recorded for that side as for the target side);
Participants must be informed about the study and voluntarily sign a written informed consent form before the trial.

Who cannot join

BMI ≥ 35 kg/m²;
The target-side osteonecrosis of the femoral head (ONFH) is classified as type M according to the China-Japan Friendship Hospital (CJFH) classification;
Inability to walk or to complete all the examinations, treatments, and follow-ups required by the trial protocol;
Currently receiving glucocorticoid pulse therapy;
Severe metabolic diseases, cardiovascular diseases, clinically significant atrial fibrillation, uncontrolled hypertension, uncontrolled asthma, symptomatic pulmonary fibrosis, recent gastrointestinal bleeding requiring transfusion, mental or psychological disorders;
History of deep vein thrombosis, with any invasive preventive/therapeutic measures taken within the last five years;

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Current fracture or infection in either hip joint, or previous surgery on the target-side hip joint;
Planned oral surgery within 54 weeks after enrollment;
Known hereditary bone diseases, such as achondroplasia, osteogenesis imperfecta, hypophosphatemic rickets, etc.;
Use of medications for bone metabolic diseases, integrins, α4β1 inhibitors/antagonists, or anti-VEGF drugs within 6 months or 5 half-lives (whichever is longer) prior to screening, as detailed in section 12.7;
Participants who have received opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), or other pain medications within 5 half-lives prior to screening;
Comorbidities that, in the investigator's judgment, may affect the clinical efficacy assessment of the hip joint, such as knee osteoarthritis, scoliosis, pelvic or lower limb deformities, etc.;
Previous allergy or contraindication to alendronate;
Any of the following abnormal laboratory findings during screening:
Phosphate level < LLN; Patients with decompensated liver function (e.g., complications of portal hypertension such as ascites, gastroesophageal variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.); Estimated glomerular filtration rate (eGFR) < 35 mL/min/1.73 m² (calculated based on creatinine using the CKD-EPI Creatinine 2009 Equation); Hemoglobin < 100 g/L; Prolonged QT interval (male > 450 msec, female > 470 msec).
Donation or loss of blood/plasma > 400 mL within 3 months prior to screening (except for physiological blood loss in females);
History of drug abuse within 2 years prior to screening;
History of substance abuse within 2 years prior to screening;
Pregnant or breastfeeding women, or female participants who have had unprotected sexual intercourse within 6 weeks prior to screening, or female participants with a positive blood pregnancy test; participants (or their partners) planning to conceive or donate sperm/eggs during the trial and for 6 months after study completion, or unwilling to use one or more contraceptive methods during the trial and for 6 months after study completion;
Participation in other drug clinical trials with medication use within 3 months prior to screening;
Participants deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Zhongshan, Guangdong, 528400

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled, Blinded, Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and PK/PD Profiles of RAB001 for Injection in Patients With Early-stage Non-traumatic Osteonecrosis Caused by Long-term Glucocorticoid Use.（LLP2A-Alendronate）

This is a multicenter, randomized (similar to drawing lots, where the treatment you receive is not chosen by you or the researchers), controlled, blinded (the three dose groups of the investigational drug are blinded, meaning neither you nor the blinded researchers will know which dose you are receiving) clinical study to evaluate the efficacy, safety, and PK/PD profiles of RAB001 for injection in patients with early-stage non-traumatic osteonecrosis caused by long-term glucocorticoid use.

A parallel-group enrollment design will be used, with a total of approximately 160 subjects expected to be enrolled (High-dose A: 1200 μg/kg；Medium-dose B: 750 μg/kg ；Low-dose C: 400 μg/kg): Control group (D: Alendronate Sodium Tablets (Fosamax) 70 mg orally once weekly) = 40 cases . If you agree to participate in this trial, you will have a 25% chance of being assigned to one of the groups mentioned above.

Supportive treatment: Calcium (recommended dose: 1000-1200 mg/d) + Vitamin D (recommended dose: 600-800 IU/d). The study physician may choose the appropriate dosage of calcium and vitamin D based on the subject's specific conditions.

Primary endpoints:

. Change in femoral head necrotic lesion volume at 48 weeks (MRI)
. Change in hip function score at 48 weeks (HHS, Harris Hip Score)

Conditions: Osteonecrosis, Osteonecrosis of the Femoral Head
Being tested: RAB001 high dose, RAB001 medium dose, RAB001 low dose, Alendronate (Fosamax)
Keywords: RAB001, LLP2A-Alendronate, Osteonecrosis of the Femoral Head
Medical subject headings: Osteonecrosis, Legg-Calve-Perthes Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RAB001 high doseDrug
Intravenous infusion RAB001 1200μg/kg
RAB001 medium doseDrug
Intravenous infusion RAB001 750μg/kg
RAB001 low doseDrug
Intravenous infusion RAB001 400μg/kg
Alendronate (Fosamax)Drug
Alendronate 70mg weekly

Study groups in NCT07471880
Study group	Role	What they receive
High-dose	Experimental	Intravenous infusion RAB001 1200μg/kg Receives: Drug: RAB001 high dose
Medium-dose	Experimental	Intravenous infusion RAB001 750μg/kg Receives: Drug: RAB001 medium dose
Low-dose	Experimental	Intravenous infusion RAB001 400μg/kg Receives: Drug: RAB001 low dose
Alendronate	Active comparator	Not described Receives: Drug: Alendronate (Fosamax)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Necrotic Area Volume of the Femoral Head (MRI)
Measured: week48
Changes in Hip Function Scores (HHS)
It is a clinical tool widely used to assess hip function and pain levels. The scoring system is administered by physicians through questionnaires and physical examinations, covering multiple dimensions such as pain, function, deformity, and range of motion.Higher scores indicate milder symptoms in patients, with a maximum of 100 points and a minimum of 0 points.
Measured: week48

Secondary outcomes (8)

Changes in the volume of the femoral head necrotic area (MRI)
Measured: week24
Changes in Hip Function Scores (HHS)
It is a clinical tool widely used to assess hip function and pain levels. The scoring system is administered by physicians through questionnaires and physical examinations, covering multiple dimensions such as pain, function, deformity, and range of motion.Higher scores indicate milder symptoms in patients, with a maximum of 100 points and a minimum of 0 points.
Measured: week24
Changes in bone mineral density (DEXA) of the proximal femur (total hip) and lumbar spine (L1-L4)
Measured: week24and week48
Rate of non-collapse of the femoral head(defined as femoral head collapse ≤ 2mm based on hip CT + MRI examination)
Measured: week24 and week48
Time to progression of osteonecrosis in the target-side femoral head compared to baseline (defined as femoral head collapse > 2mm based on hip CT + MRI examination)
Measured: week48
Changes in WOMAC scores
The WOMAC score is one of the most widely used tools in hip or knee osteoarthritis research and clinical practice. It comprises three subscales: Pain, Stiffness, and Physical Function. Lower scores indicate milder symptoms in patients, with the scale ranging from a minimum of 0% to a maximum of 100%.
Measured: week24 and week48
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: week 48
Incidence of anti-drug antibodies (ADA)
Measured: week1、week7、week25、week49 week53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Dec 202428 Feb 2027

First posted13 Mar 2026
Study start24 Dec 2024
Primary completion10 Oct 2026 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteonecrosisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07471880
Sponsor's protocol ID: LBRC-RAB001-201
Acronym: LLP2A-Ale
Status last verified: Mar 2026
First submitted: 28 Feb 2026
Last updated: 24 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Based on a comprehensive consideration of ethical compliance (informed consent), legal constraints, protection of commercial interests, and operational feasibility, individual participant data (IPD) will not be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Z1 Hip System: Post-Market Clinical Follow Up Study
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All Osteonecrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Controlled, Blinded, Phase II Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and PK/PD Profiles of RAB001 for Injection in Patients With Early-stage Non-traumatic Osteonecrosis Caused by Long-term Glucocorticoid Use.（LLP2A-Alendronate）
ClinicalTrials.gov ID: NCT07471880
Acronym / sponsor ID: LLP2A-Ale / LBRC-RAB001-201
Conditions: Osteonecrosis, Osteonecrosis of the Femoral Head
Keywords: RAB001, LLP2A-Alendronate, Osteonecrosis of the Femoral Head
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 161 participants (actual)
Lead sponsor: ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.Other government
Study start: 24 Dec 2024 (actual)
Primary completion: 10 Oct 2026 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 13 Mar 2026 (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.

Primary endpoints:

. Change in femoral head necrotic lesion volume at 48 weeks (MRI)
. Change in hip function score at 48 weeks (HHS, Harris Hip Score)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High-dose	Experimental	Drug: RAB001 high doseIntravenous infusion RAB001 1200μg/kg
Medium-dose	Experimental	Drug: RAB001 medium doseIntravenous infusion RAB001 750μg/kg
Low-dose	Experimental	Drug: RAB001 low doseIntravenous infusion RAB001 400μg/kg
Alendronate	Active comparator	Drug: Alendronate (Fosamax)

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years ≤ age ≤ 69 years, gender not limited;
Patients with glucocorticoid-induced osteonecrosis of the femoral head (ONFH) according to the 2019 edition of the "Guidelines for clinical diagnosis and treatment of osteonecrosis of the femoral head in adults", with an ARCO stage of II, and confirmed by CT and MRI examinations to have no femoral head collapse, and the time from first glucocorticoid use to the screening period must exceed 30 days;
The participant has no plans for hip surgery on the target side within the next 54 weeks;
Participants with unilateral or bilateral ONFH are not restricted. For unilateral involvement, the affected side (as the target side) must have no femoral head collapse confirmed by hip CT examination. For bilateral involvement, hip CT examination must confirm that at least one side has no collapse (the non-collapsed side is the target side; if both sides are necrotic and neither has collapsed, the side with more severe necrosis is the target side. If the contralateral side of the target side meets the criteria for study-defined osteonecrosis, all study information must be recorded for that side as for the target side);
Participants must be informed about the study and voluntarily sign a written informed consent form before the trial.

Key exclusion criteria (21 listed)

BMI ≥ 35 kg/m²;
The target-side osteonecrosis of the femoral head (ONFH) is classified as type M according to the China-Japan Friendship Hospital (CJFH) classification;
Inability to walk or to complete all the examinations, treatments, and follow-ups required by the trial protocol;
Currently receiving glucocorticoid pulse therapy;
Severe metabolic diseases, cardiovascular diseases, clinically significant atrial fibrillation, uncontrolled hypertension, uncontrolled asthma, symptomatic pulmonary fibrosis, recent gastrointestinal bleeding requiring transfusion, mental or psychological disorders;

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
RAB001 high doseIntravenous infusion RAB001 1200μg/kg	Drug	High-dose
RAB001 medium doseIntravenous infusion RAB001 750μg/kg	Drug	Medium-dose
RAB001 low doseIntravenous infusion RAB001 400μg/kg	Drug	Low-dose
Alendronate (Fosamax)Alendronate 70mg weekly	Drug	Alendronate

Primary outcome

Changes in Necrotic Area Volume of the Femoral Head (MRI)
Time frame: week48
Changes in Hip Function Scores (HHS)
Time frame: week48
It is a clinical tool widely used to assess hip function and pain levels. The scoring system is administered by physicians through questionnaires and physical examinations, covering multiple dimensions such as pain, function, deformity, and range of motion.Higher scores indicate milder symptoms in patients, with a maximum of 100 points and a minimum of 0 points.

8 secondary outcomes

Changes in the volume of the femoral head necrotic area (MRI)
Time frame: week24
Changes in Hip Function Scores (HHS)
Time frame: week24
Changes in bone mineral density (DEXA) of the proximal femur (total hip) and lumbar spine (L1-L4)
Time frame: week24and week48
Rate of non-collapse of the femoral head(defined as femoral head collapse ≤ 2mm based on hip CT + MRI examination)
Time frame: week24 and week48
Time to progression of osteonecrosis in the target-side femoral head compared to baseline (defined as femoral head collapse > 2mm based on hip CT + MRI examination)
Time frame: week48
Changes in WOMAC scores
Time frame: week24 and week48
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: week 48
Incidence of anti-drug antibodies (ADA)
Time frame: week1、week7、week25、week49 week53

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Individual participant dataSharing planned: No. Based on a comprehensive consideration of ethical compliance (informed consent), legal constraints, protection of commercial interests, and operational feasibility, individual participant data (IPD) will not be shared.

Related trials for Osteonecrosis

Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 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: under way, not looking for participants, as of the sponsor's last update on 24 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 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Changes in Necrotic Area Volume of the Femoral Head (MRI) (time frame: week48). The study lists 2 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 NCT07471880.

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 Mar 2026.