Age-related Macular DegenerationPhase 2NCT01397409

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

A Phase 2 study testing AGN-150998 and ranibizumab in people with Age-related Macular Degeneration, run by Allergan at 8 sites in 8 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Age-related Macular Degeneration
What is being tested?: AGN-150998 and ranibizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 271 participants
Where: 8 sitesin 8 countries
Study dates: 1 Sep 2011to 30 Apr 2014
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Exudative age-related macular degeneration
Best-corrected visual acuity between 20/32 and 20/320 in the study eye

Who cannot join

Near-sightedness of 8 diopters or more
Uncontrolled glaucoma in the study eye
Cataract surgery or Lasik within the last 3 months
Any active ocular infection or inflammation

Trial locations and contacts

8 sites in 8 countries.

Country

City, postcode or hospital

8 sites in 8 countries

United States1 site

Study site
Phoenix, Arizona

Other trials in United States

Australia1 site

Study site
Sydney, New South Wales

Other trials in Australia

Austria1 site

Study site
Vienna

Other trials in Austria

France1 site

Study site
Créteil

Other trials in France

Germany1 site

Study site
Bonn

Other trials in Germany

Israel1 site

Study site
Tel Aviv

Other trials in Israel

Italy1 site

Study site
Florence

Other trials in Italy

Switzerland1 site

Study site
Binningen

Other trials in Switzerland

About this study

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

Conditions: Age-related Macular Degeneration
Being tested: AGN-150998, ranibizumab, Sham Injection
Medical subject headings: Macular Degeneration

What participants receive

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

AGN-150998Drug
AGN-150998 Intravitreal injection.
ranibizumabDrug
Also called Lucentis®
Ranibizumab 0.5 mg given by intravitreal injection.
Sham InjectionOther
Stage 3: Sham injection at Weeks 12 and 16.

Study groups in NCT01397409
Study group	Role	What they receive
Stage 1: AGN-150998 4.2 mg	Experimental	Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection. Receives: Drug: AGN-150998
Stage 1: AGN-150998 3.0 mg	Experimental	Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection. Receives: Drug: AGN-150998
Stage 1: AGN-150998 2.0 mg	Experimental	Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection. Receives: Drug: AGN-150998
Stage 1: AGN-150998 1.0 mg	Experimental	Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection. Receives: Drug: AGN-150998
Stage 2: AGN-150998 4.2 mg	Experimental	Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. Receives: Drug: AGN-150998
Stage 2: AGN-150998 3.0 mg	Experimental	Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. Receives: Drug: AGN-150998
Stage 2: ranibizumab 0.5 mg	Active comparator	Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. Receives: Drug: ranibizumab
Stage 3: AGN-150998 2.0 mg	Experimental	Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. Receives: Drug: AGN-150998; Other: Sham Injection
Stage 3: AGN-150998 1.0 mg	Experimental	Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. Receives: Drug: AGN-150998; Other: Sham Injection
Stage 3: ranibizumab 0.5 mg	Active comparator	Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks. Receives: Drug: ranibizumab

What is being measured

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

Highest Tolerated Dose (HTD) of AGN-150998
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Measured: 24 Weeks
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 4
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
Measured: Baseline, Week 16
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Week 16

Secondary outcomes (5)

Stage 2: Time Between Second Treatment and Recurrence of Active Disease
Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.
Measured: 32 Weeks
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 4
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Week 4
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 4
Stage 3: Change From Baseline in BCVA in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Week 4

Timeline

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

1 Sep 201130 Apr 2014

First posted19 Jul 2011 (estimated)
Study start1 Sep 2011
Primary completion31 Mar 2014
Study completion30 Apr 2014

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 Age-related Macular DegenerationStudies 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: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01397409
Sponsor's protocol ID: 150998-001
Other IDs: 2011-002526-43, REACH Study
Status last verified: Apr 2019
First submitted: 18 Jul 2011
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, Lopez FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.
PubMed 30412448

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

RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
ClinicalTrials.gov ID: NCT01397409
Acronym / sponsor ID: 150998-001
Conditions: Age-related Macular Degeneration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 Sep 2011 (actual)
Primary completion: 31 Mar 2014 (actual)
Study completion: 30 Apr 2014 (actual)
First posted: 19 Jul 2011 (estimated)
Results: Posted 18 Jun 2015

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Stage 1: AGN-150998 4.2 mg	Experimental	Drug: AGN-150998Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
Stage 1: AGN-150998 3.0 mg	Experimental	Drug: AGN-150998Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
Stage 1: AGN-150998 2.0 mg	Experimental	Drug: AGN-150998Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
Stage 1: AGN-150998 1.0 mg	Experimental	Drug: AGN-150998Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
Stage 2: AGN-150998 4.2 mg	Experimental	Drug: AGN-150998Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Stage 2: AGN-150998 3.0 mg	Experimental	Drug: AGN-150998Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Stage 2: ranibizumab 0.5 mg	Active comparator	Drug: ranibizumabStage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Stage 3: AGN-150998 2.0 mg	Experimental	Drug: AGN-150998, Other: Sham InjectionStage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Stage 3: AGN-150998 1.0 mg	Experimental	Drug: AGN-150998, Other: Sham InjectionStage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Stage 3: ranibizumab 0.5 mg	Active comparator	Drug: ranibizumabStage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Exudative age-related macular degeneration
Best-corrected visual acuity between 20/32 and 20/320 in the study eye

Key exclusion criteria (4 listed)

Near-sightedness of 8 diopters or more
Uncontrolled glaucoma in the study eye
Cataract surgery or Lasik within the last 3 months
Any active ocular infection or inflammation

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
AGN-150998AGN-150998 Intravitreal injection.	Drug	Stage 1: AGN-150998 1.0 mg, Stage 1: AGN-150998 2.0 mg, Stage 1: AGN-150998 3.0 mg, Stage 1: AGN-150998 4.2 mg, Stage 2: AGN-150998 3.0 mg, Stage 2: AGN-150998 4.2 mg, Stage 3: AGN-150998 1.0 mg, Stage 3: AGN-150998 2.0 mg
ranibizumabAlso: Lucentis®Ranibizumab 0.5 mg given by intravitreal injection.	Drug	Stage 2: ranibizumab 0.5 mg, Stage 3: ranibizumab 0.5 mg
Sham InjectionStage 3: Sham injection at Weeks 12 and 16.	Other	Stage 3: AGN-150998 1.0 mg, Stage 3: AGN-150998 2.0 mg

Primary outcome

Highest Tolerated Dose (HTD) of AGN-150998
Time frame: 24 Weeks
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 4
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
Time frame: Baseline, Week 16
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Week 16
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

5 secondary outcomes

Stage 2: Time Between Second Treatment and Recurrence of Active Disease
Time frame: 32 Weeks
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 4
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Week 4
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 4
Stage 3: Change From Baseline in BCVA in the Study Eye
Time frame: Baseline, Week 4

Results and safety

Results posted to the registry on 18 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1: AGN-150998 4.2 mg	9	9
Stage 1: AGN-150998 3.0 mg	6	6
Stage 1: AGN-150998 2.0 mg	6	6
Stage 1: AGN-150998 1.0 mg	3	3
Stage 2: AGN-150998 4.2 mg	0	0
Stage 2: AGN-150998 3.0 mg	0	0
Stage 2: Ranibizumab 0.5 mg	0	0
Stage 3: AGN-150998 2.0 mg	0	0
Stage 3: AGN-150998 1.0 mg	0	0
Stage 3: Ranibizumab 0.5 mg	0	0

Primary outcome: Highest Tolerated Dose (HTD) of AGN-150998

Time frame: 24 Weeks. Number. Unit: mg

Measure	Stage 1 All Participants n = 24
Value	4.2

Population analysed: Safety population included all treated participants.

Primary outcome: Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: microns

Measure	Stage 1: AGN-150998 4.2 mg n = 9	Stage 1: AGN-150998 3.0 mg n = 6	Stage 1: AGN-150998 2.0 mg n = 6	Stage 1: AGN-150998 1.0 mg n = 3
Baseline	527.6 (126.79)	540.3 (284.34)	500.3 (155.65)	564.3 (115.68)
Change from Baseline at Week 4 (n=9,6,6,2)	-185.4 (161.23)	-239.5 (234.03)	-212.3 (182.94)	-113.5 (135.06)

Population analysed: Safety population included all treated participants.

Primary outcome: Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease

Time frame: Baseline, Week 16. Median (Inter-Quartile Range). Unit: days

Measure	Stage 2: AGN-150998 4.2 mg n = 65	Stage 2: AGN-150998 3.0 mg n = 57	Stage 2: Ranibizumab 0.5 mg n = 57
Value	59.0 (43.0 to 109.0)	57.0 (43.0 to 86.0)	57.0 (43.0 to 85.0)

Population analysed: Per-protocol Population included all treated participants who received all scheduled treatments.

Primary outcome: Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

Time frame: Baseline, Week 16. Mean (Standard Deviation). Unit: letters

Measure	Stage 3: AGN-150998 2.0 mg n = 23	Stage 3: AGN-150998 1.0 mg n = 25	Stage 3: Ranibizumab 0.5 mg n = 16
Baseline	58.5 (14.29)	58.4 (13.49)	60.4 (16.41)
Change from Baseline at Week 16	8.2 (7.89)	6.3 (7.81)	5.3 (11.08)

Population analysed: Modified-Intent-to-Treat (mITT) Population

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: AGN-150998 4.2 mg	0 of 9 (0%)	3 of 9 (33.3%)	Not reported
Stage 1: AGN-150998 3.0 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Stage 1: AGN-150998 2.0 mg	1 of 6 (16.7%)	4 of 6 (66.7%)	Not reported
Stage 1: AGN-150998 1.0 mg	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Stage 2: AGN-150998 4.2 mg	11 of 67 (16.4%)	51 of 67 (76.1%)	Not reported
Stage 2: AGN-150998 3.0 mg	6 of 58 (10.3%)	35 of 58 (60.3%)	Not reported
Stage 2: Ranibizumab 0.5 mg	5 of 58 (8.6%)	35 of 58 (60.3%)	Not reported
Stage 3: AGN-150998 2.0 mg	0 of 23 (0%)	10 of 23 (43.5%)	Not reported
Stage 3: AGN-150998 1.0 mg	0 of 25 (0%)	15 of 25 (60%)	Not reported
Stage 3: Ranibizumab 0.5 mg	0 of 16 (0%)	9 of 16 (56.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30412448Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, Lopez FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.

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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.

Medical Director study director

Allergan

8 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGN-150998 and ranibizumab in people with Age-related Macular Degeneration, run by Allergan at 8 sites in 8 countries.

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 2 inclusion and 4 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia, Austria, France, Germany and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 18 Jun 2015). 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?

Highest Tolerated Dose (HTD) of AGN-150998 (time frame: 24 Weeks). The study lists 4 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 NCT01397409, 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 16 Apr 2019.