Ankylosing Spondylitis (AS)Phase 2NCT02047110

BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)

A Phase 2 study testing risankizumab in people with Ankylosing Spondylitis (AS), run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Ankylosing Spondylitis (AS)
What is being tested?: risankizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: No sites listed yet
Study dates: 28 Jan 2014to 25 Jul 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 and female patients
Age = 18 years and = 70 years
Definite AS based on the modified New York criteria (1984)
Documented disease duration = 3 months at screening
Active disease at screening, defined as:
BASDAI score (0-10) = 4, AND

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Spinal pain level assessed by the 2nd BASDAI question (0-10) = 4
Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
Female patients who meet any of the following criteria from screening visit up to the End of Observation visit (EOO):
using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
sexually abstinent
have a vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
surgically sterilised (including hysterectomy)
postmenopausal defined as at least 1 year of spontaneous Amenorrhea
Patients (males or females) receiving background MTX or Leflunomide therapy who are following the national regulatory guidelines regarding contraception
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Who cannot join

Radiographic evidence of total ankylosis of the spine at screening or before (spinal XRay examinations at screening visit/ during screening period are not mandatory ¿ see footnote 12 from Flow-Chart 1)
Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
Previous or current participation in a clinical trial testing an investigational drug for AS within 12 weeks prior to randomization (any biological immunomodulating agents are excluded)
Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
Active uveitis or inflammatory bowel disease at screening
Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria

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Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
Patients who must or wish to continue the intake of restricted medications (cf. Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the study
Major surgery performed within 8 weeks prior to screening or planned within 12 months after screening (e.g. hip replacement)
Chronic or relevant acute infections including HIV, viral hepatitis and tuberculosis (positive tests for HIV, HBV/HCV at screening will be exclusionary)
For tuberculosis patients, they are not eligible according to the following screening criteria:
Have signs or symptoms suggestive of current active or latent TB upon medical history, physical examination and/or a chest radiograph (both posterior-anterior and lateral views, taken within 3 months prior to the first administration of study drug and read by a qualified radiologist)
Have history of latent or active TB prior to screening, except for patients who have documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or during screening, in which active TB has not been ruled out, except for patients with history of latent TB and documentation of having completed an adequate treatment regimen at least 6 months prior to the first administration of study agent
Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix
Evidence of current or previous clinically significant disease, medical condition other than AS, finding of the medical examination (including vital signs and ECG), or laboratory value at the screening visit outside the reference range that is of clinical relevance, that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
History of alcohol abuse within last 12 months (intake of more than 30 g/day)
History of drug abuse within last 12 months

About this study

Official title: A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.

Conditions: Ankylosing Spondylitis (AS)
Being tested: placebo for risankizumab, risankizumab
Medical subject headings: Spondylitis, Ankylosing

What participants receive

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

placebo for risankizumabDrug
Placebo for risankizumab administered by subcutaneous (SC) injection
risankizumabDrug
Also called ABBV-066, BI 655066, SKYRIZI
Risankizumab administered by subcutaneous (SC) injection

Study groups in NCT02047110
Study group	Role	What they receive
Placebo	Placebo comparator	Subcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period. Receives: Drug: placebo for risankizumab
Risankizumab 18 mg	Experimental	Subcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks Receives: Drug: risankizumab
Risankizumab 90 mg	Experimental	Subcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Receives: Drug: risankizumab
Risankizumab 180 mg	Experimental	Subcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period Receives: Drug: risankizumab

What is being measured

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

Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
- Global AS disease activity
- Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
- Spinal pain based on the mean of 2 questions
- Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.
Measured: Week 12

Secondary outcomes (6)

Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
This is the key secondary endpoint. ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient's global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit. ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1). For all of the scales that make up the ASDAS, higher indicates worse disease.
Measured: Baseline and Week 12
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
The ASAS 5/6 evaluation is based on 6 components:
- Global AS disease activity
- Inflammation based on the mean of BASDAI questions addressing the level-of morning stiffness and duration
- Spinal pain
- Physical function based on the Bath AS Functional Index (BASFI)
- Spinal mobility assessment (lateral lumbar flexion), corresponding to one out of 5 measurements of Bath Ankylosing Spondylitis Metrology Index (BASMI)
- Serum CRP levels The ASAS 5/6 response is defined as an improvement in any 5 of the 6 components and no worsening in the remaining component. A reduction from baseline of ≥20% is defined as an improvement according to the ASAS criteria.
Measured: Week 12
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented
Measured: Week 12
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:
- Global AS disease activity
- Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration
- Spinal pain based on the mean of 2 questions
- Physical function based on the Bath AS Functional Index (BASFI) The ASAS 20 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥20% and an absolute reduction of ≥1 units in each of the 3 components.
Measured: Week 12
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of
1. fatigue/tiredness you have experienced?
2. AS neck, back or hip pain you have had?
3. pain/swelling in joints other than neck, back or hips you have had?
4. discomfort you have had from any areas tender to touch or pressure?
5. morning stiffness you have had from the time you wake up? How long does your
6. morning stiffness last from the time you wake up?
A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h.
The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5.
Measured: Baseline and Week 12
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented
Measured: Week 24

Timeline

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

28 Jan 201425 Jul 2016

First posted28 Jan 2014 (estimated)
Study start28 Jan 2014
Primary completion5 Mar 2015
Study completion25 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: Double blind
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047110
Sponsor's protocol ID: 1311.8
Other IDs: 2013-003666-13
Status last verified: May 2019
First submitted: 24 Jan 2014
Last updated: 31 May 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Baeten D, Ostergaard M, Wei JC, Sieper J, Jarvinen P, Tam LS, Salvarani C, Kim TH, Solinger A, Datsenko Y, Pamulapati C, Visvanathan S, Hall DB, Aslanyan S, Scholl P, Padula SJ. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Ann Rheum Dis. 2018 Sep;77(9):1295-1302. doi: 10.1136/annrheumdis-2018-213328. Epub 2018 Jun 26.
PubMed 29945918

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?

Official record

Not yet recruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Not yet recruitingPhase 4
Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis
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Not yet recruiting
Posture Exercises in Ankylosing Spondylitis
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Active, not recruiting
Effects of Pulmonary Rehabilitation Exercises in Patients With Axial Spondyloarthritis
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Not yet recruiting
Postural Biofeedback and Exercise in Axial Spondyloarthritis
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All Ankylosing Spondylitis (AS) trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
ClinicalTrials.gov ID: NCT02047110
Acronym / sponsor ID: 1311.8
Conditions: Ankylosing Spondylitis (AS)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: 28 Jan 2014 (actual)
Primary completion: 5 Mar 2015 (actual)
Study completion: 25 Jul 2016 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo for risankizumabSubcutaneous injection of Placebo (solution for injection matching risankizumab, 1 mL pre-filled syringe) administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period.
Risankizumab 18 mg	Experimental	Drug: risankizumabSubcutaneous injection of risankizumab 18 mg administered every 8 weeks at Day 1 only, followed by placebo every 8 weeks (i.e. at Week 8, 16 and 24), up to a total duration of 24 weeks
Risankizumab 90 mg	Experimental	Drug: risankizumabSubcutaneous injection of risankizumab 90 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period
Risankizumab 180 mg	Experimental	Drug: risankizumabSubcutaneous injection of risankizumab 180 mg administered every 8 weeks (At Day1 and at Weeks 8, 16, and 24) up to 4 times during the regular treatment period

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male and female patients
Age = 18 years and = 70 years
Definite AS based on the modified New York criteria (1984)
Documented disease duration = 3 months at screening
Active disease at screening, defined as:

Key exclusion criteria (19 listed)

Radiographic evidence of total ankylosis of the spine at screening or before (spinal XRay examinations at screening visit/ during screening period are not mandatory ¿ see footnote 12 from Flow-Chart 1)
Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
Previous or current participation in a clinical trial testing an investigational drug for AS within 12 weeks prior to randomization (any biological immunomodulating agents are excluded)
Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
Active uveitis or inflammatory bowel disease at 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
placebo for risankizumabPlacebo for risankizumab administered by subcutaneous (SC) injection	Drug	Placebo
risankizumabAlso: ABBV-066, BI 655066, SKYRIZIRisankizumab administered by subcutaneous (SC) injection	Drug	Risankizumab 18 mg, Risankizumab 180 mg, Risankizumab 90 mg

Primary outcome

Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.
Time frame: Week 12
ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status: * Global AS disease activity * Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration * Spinal pain based on the mean of 2 questions * Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components.

6 secondary outcomes

Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).
Time frame: Baseline and Week 12
Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12
Time frame: Week 12
Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12
Time frame: Week 12
Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12
Time frame: Week 12
Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI
Time frame: Baseline and Week 12
Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24
Time frame: Week 24

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	35
Risankizumab 18 mg	40	38
Risankizumab 90 mg	39	36
Risankizumab 180 mg	40	38

Primary outcome: Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	Placebo n = 40	Risankizumab 18 mg n = 40	Risankizumab 90 mg n = 39	Risankizumab 180 mg n = 40
Value	17.5	25.0	20.5	15.0

Placebo vs Risankizumab 18 mg: Risk Difference (RD): 7.5 (90% CI -12.1 to 26.6), p = 0.2652, Suissa-Shuster unconditional exact test
Placebo vs Risankizumab 90 mg: Risk Difference (RD): 3.0 (90% CI -15.9 to 20.8), p = 0.4129, Suissa-Shuster unconditional exact test
Placebo vs Risankizumab 180 mg: Risk Difference (RD): -2.5 (90% CI -21.8 to 17.0), p = 0.4243, Suissa-Shuster unconditional exact test

Population analysed: Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events reported during the DB, the Escape, and the OLE treatment period; up to 50 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 40 (5%)	21 of 40 (52.5%)	Not reported
Risankizumab 18 mg	0 of 40 (0%)	21 of 40 (52.5%)	Not reported
Risankizumab 90 mg	2 of 39 (5.1%)	22 of 39 (56.4%)	Not reported
Risankizumab 180 mg	2 of 40 (5%)	22 of 40 (55%)	Not reported
Escape Low	1 of 47 (2.1%)	10 of 47 (21.3%)	Not reported
Escape High	2 of 48 (4.2%)	17 of 48 (35.4%)	Not reported
Escape	3 of 95 (3.2%)	27 of 95 (28.4%)	Not reported
Open Label Extension (OLE)	1 of 26 (3.8%)	11 of 26 (42.3%)	Not reported
Risankizumab High	9 of 138 (6.5%)	85 of 138 (61.6%)	Not reported
Risankizumab Total	9 of 149 (6%)	91 of 149 (61.1%)	Not reported
Total_all	10 of 159 (6.3%)	99 of 159 (62.3%)	Not reported

Limitations and caveats (from the sponsor): The hierarchical testing p-values are exploratory in nature, due to the study design, as the primary endpoint of study failed to meet the desired objective.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29945918Baeten D, Ostergaard M, Wei JC, Sieper J, Jarvinen P, Tam LS, Salvarani C, Kim TH, Solinger A, Datsenko Y, Pamulapati C, Visvanathan S, Hall DB, Aslanyan S, Scholl P, Padula SJ. Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Ann Rheum Dis. 2018 Sep;77(9):1295-1302. doi: 10.1136/annrheumdis-2018-213328. Epub 2018 Jun 26.
Related InfoLink provided by the sponsor.

Related trials for Ankylosing Spondylitis (AS)

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing risankizumab in people with Ankylosing Spondylitis (AS), run by AbbVie.

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 16 inclusion and 19 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

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 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?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12. (time frame: Week 12). 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 NCT02047110, 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 31 May 2019.